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ANNUAL
REPORT
2021
GLOBAL LEADER
IN ALLOGENEIC
CELLULAR MEDICINES
FOR INFLAMMATORY
DISEASES
CONTENTS
MESSAGE FROM THE CHAIRMAN
CHIEF EXECUTIVE’S REPORT
FORM 20-F
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SHAREHOLDER INFORMATION 217
CORPORATE DIRECTORY 219
CORPORATE GOVERNANCE
Mesoblast Limited and its Board of Directors are committed to implementing and achieving an effective corporate
governance framework to ensure that the Company is managed effectively and in an honest and ethical way.
The Company’s Corporate Governance statement for the financial year ending 30 June 2021 has been approved by
the Board and is available on our website at http://www.mesoblast.com/company/corporate-governance
MESSAGE FROM THE CHAIRMAN
Joseph R. Swedish
Chairman
Dear shareholders,
Twelve months ago, when I penned my last shareholders’ letter,
I began by describing the unprecedented impacts we were all
facing due to the global coronavirus pandemic. In hindsight,
the impacts have reached far further and weighed far deeper
than any of us could then have imagined, touching – and often
devastating – so many aspects of our lives.
As a global community, we have demonstrated remarkable
resilience, compassion, and ingenuity in facing the pandemic.
I am proud to have seen these same qualities reflected at all
levels of the Mesoblast team as we continue to navigate the
hurdles to make our lead therapy, remestemcel-L, available
to those children who – after having faced the trauma of bone
marrow transplants – face the life-threatening condition of
steroid-refractory acute graft versus host disease (SR-aGVHD).
Following a presentation of study results from children with
SR-aGVHD treated with remestemcel-L at the US Food and
Drug Administration’s (FDA) advisory panel mid last year,
with the advisory panel voting overwhelmingly in favor that
the available data support the efficacy of remestemcel-L in
children with SR-aGVHD, we were disappointed when an
approval did not materialise. Nonetheless, we have regrouped
and the management team has been focused on addressing
the outstanding items that the FDA has requested. We are
confident that, after extensive work and a collegial collaboration
with the agency to date, these efforts could lead to a
resubmission of the current Biologic License Application.
The additional investments we have made with respect to
remestemcel-L will also support commencement of the next
Phase 3 trial for acute respiratory distress syndrome (ARDS)
associated with COVID-19 which continues to devastate
communities with a high mortality rate. Results from our first
COVID ARDS trial which read-out earlier this year, together with
the recent constructive meeting with the FDA, pave the way for
a highly anticipated follow-up study and a pathway to potential
emergency use authorization for patients with the highest risk
of death for whom there are no adequate treatments.
The Directors are committed to implementing and achieving
an effective corporate governance framework with the full
details laid out in the company’s 2021 Corporate Governance
Statement. A major focus of the Board is to increase
diversity and to maintain a program of renewal that provides
regular rotation of Board membership to ensure continued
independence, and addition of fresh skills and experience
relevant to Mesoblast’s progression toward commercialization,
whilst maintaining the balance of incumbent corporate history
and tenure.
It has been a monumental period in the history of Mesoblast,
and the year ahead has several upcoming milestones across
our portfolio which target some of our greatest public health
challenges.
Lastly, but importantly, I would like to thank our Chief Executive
Dr Silviu Itescu, management team and all our employees for
their resilience, resourcefulness, and unswerving dedication
over the past 12 months. I would also like to thank our
investors, who continue to show faith in the lifesaving potential
of our allogeneic therapies – and in the exemplary scientific
credentials of our team.
Yours sincerely,
Joseph R. Swedish
Chairman
MESOBLAST LIMITED 2021 ANNUAL REPORT 1
CHIEF EXECUTIVE’S REPORT
Dr Silviu Itescu
Chief Executive
Dear shareholders,
Without a doubt the last 18 months of living and operating
during the global pandemic have created an unprecedented
level of uncertainty for all of us. This is the reason why I am so
appreciative and inspired by the level of commitment I have
witnessed from the Mesoblast team. Our people have remained
focussed, dedicated, and committed to our goal of bringing
lifesaving medicines to patients with inflammatory diseases
that have high unmet need and are often accompanied by
high risk of mortality.
During the last twelve months much has been achieved.
The Mesoblast team has continued to work tirelessly towards
a potential resubmission of the Biologics License Application
(BLA) for steroid-refractory graft versus host disease
(SR-aGVHD), having received the complete response letter
last year, despite a successful advisory committee meeting
convened by the US Food and Drug Administration (FDA).
We look forward to our upcoming discussions with the FDA,
and believe we are well positioned to adequately address the
remaining items regarding chemistry, manufacturing,
and controls (CMC), including potency assays.
With an understanding of shared mechanisms of inflammation
responsible for various diseases, we effectively leveraged our
extensive body of clinical data in the treatment of SR-aGVHD
to rapidly pivot to evaluating the potential of remestemcel-L to
reduce mortality in acute respiratory distress syndrome (ARDS)
due to COVID-19. Despite the complexity of running a large
trial during a pandemic whilst treatment modalities continually
evolved, we were able to identify a strong signal of efficacy
in younger patients with inflammation where mortality remains
a major unmet need. This exemplifies the strength and
breadth of our platform technology and our ability to adapt
to emerging challenges and opportunities.
We are particularly pleased to see the peer reviewed recognition
of our rexlemestrocel-L Phase 3 chronic heart failure (CHF) trial
results which will be showcased in a late-breaking session at
the American Heart Association’s (AHA) Scientific Sessions,
regarded as the world’s most prestigious cardiovascular
meeting. The featured session is titled ‘Building on the
Foundations of Treatment: Advances in Heart Failure Therapy.’
Separately, the Mesoblast team will present these clinical
results to the FDA in order to receive guidance on the pathway
to potential approval for rexlemestrocel-L in the treatment
of CHF.
These achievements are the result of continued strategic
investment in our pipeline and into the manufacturing objectives
that underpin our ability to bring our late-stage product
2 MESOBLAST LIMITED 2021 ANNUAL REPORT
candidates to market. The company is well positioned in
the next six to twelve months to make substantial progress
in its plans for product commercialization.
Remestemcel-L
Results published in the September issue of the peer-reviewed
journal Bone Marrow Transplantation showed that children with
SR-aGVHD and biomarkers predictive for highest mortality had
64% survival when treated with remestemcel-L compared with
only 10% survival when treated with other available therapies,
including ruxolitinib or other biologics.
These data provide further support for the proposed anti-
inflammatory mechanism of action of remestemcel-L and its
immunomodulatory activity in patients with SR-aGVHD, resulting
in improved survival outcomes. At our upcoming scheduled
meeting with FDA’s Office of Tissue and Advanced Therapies
(OTAT), Mesoblast will address the appropriateness of potency
assays related to remestemcel-L’s proposed anti-inflammatory
mechanism of action as well as the outstanding CMC items
which could support a resubmission of the current BLA for
remestemcel-L in the treatment of SR-aGVHD in children.
Results from the randomized controlled trial of remestemcel-L
in 222 ventilator-dependent COVID-19 patients with moderate/
severe ARDS provided 90-day survival outcomes showing
remestemcel-L significantly reduced mortality by 48% at 90
days compared to controls in a pre-specified exploratory
analysis of 123 treated patients under 65 years old. Despite a
treatment-related improvement in respiratory function at day 7,
there was no mortality reduction in the 97 treated patients over
age 65, suggesting the potential need for more prolonged or
higher dosing of anti-inflammatory therapy in these patients
who may have a more exuberant inflammatory response
associated with defective immune-mediated viral clearance
mechanisms.
These results were discussed in our most recent meeting with
the FDA where clarity was provided on the pathway towards
an emergency use authorization (EUA) for remestemcel-L
in the treatment of COVID ARDS. The FDA advised that an
additional clinical study would be required which, if statistically
positive, could provide a dataset in conjunction with the recently
completed study that might be sufficient to support an EUA.
During the year, Mesoblast entered into a license and
collaboration agreement with Novartis for the development,
manufacture, and commercialization of remestemcel-L, with
an initial focus on the treatment of acute respiratory distress
syndrome including that associated with COVID-19. The
agreement remains subject to certain closing conditions,
including time to analyze the results from the COVID-19
ARDS trial.
intervertebral disc has occurred, Mesoblast will receive
feedback shortly from the FDA on the pathway to US regulatory
approval in these patients.
Rexlemestrocel-L
Investing in Our Business and Our People
Despite newer therapies that have reduced hospitalizations
due to reversible volume-related events in heart failure with
reduced left ventricular ejection fraction (HFrEF), these patients
remain at high risk for cardiac death, heart attacks and strokes
due to ongoing inflammation. Rexlemestrocel-L is being
developed as an immunomodulatory therapy to address the
high degree of intra-cardiac and systemic inflammation in
chronic heart failure in order to reduce the high rate of major
adverse cardiac events (MACE) in these patients.
The results from the company’s landmark DREAM-HF
randomized controlled trial in 537 treated patients with
HFrEF who received rexlemestrocel-L (REVASCOR®) or
control sham, showed that while volume overload related
hospitalizations were not reduced over maximal standard of
care, a single dose of rexlemestrocel-L resulted in substantial
and durable reductions in heart attacks, strokes, and cardiac
deaths. The results of this trial identify New York Heart
Association (NYHA) Class II HFrEF patients as the optimal
target population for greatest rexlemestrocel-L treatment effect,
with the potential to delay or prevent progression to NYHA
Class III and beyond. This represents the largest potential
market opportunity in HFrEF. The trial’s co-principal investigator
Dr Emerson Perin, Medical Director of Texas Heart Institute,
and Clinical Professor, Baylor College of Medicine, will give
the late breaking presentation at the upcoming AHA annual
meeting, titled ‘Randomized Trial of Targeted Transendocardial
Delivery of Mesenchymal Precursor Cells in High-Risk Chronic
Heart Failure Patients with Reduced Ejection Fraction’. Late-
Breaking Science sessions are innovative and provide the
latest breakthroughs in clinical science. These sessions provide
notable exposure and recognition for studies likely to have a
significant impact on clinical practice and/or to make significant
advances in a scientific field.
There is a significant unmet need for a safe, efficacious,
and durable opioid-sparing treatment in patients with
chronic low back pain (CLBP) due to severely inflamed
degenerative disc disease. In view of the findings from our
recent Phase 3 trial in CLBP patients that a single injection of
rexlemestrocel-L + hyaluronic acid carrier may provide a safe,
durable, and effective opioid-sparing therapy, and that the
greatest benefits are seen when administered earlier in
the disease process before irreversible fibrosis of the
While we invest across the business, our near-term objective
is to gain FDA marketing approval for remestemcel-L in the US
and to prepare for a successful commercial launch. During the
period we have focused our investment to support the pathway
to potential approval, manufacturing scale up, life cycle
management, and the team with the necessary know-how
to execute our commercial objectives.
Work has progressed substantially on Mesoblast’s proprietary
manufacturing technologies which facilitate the increase in
yields necessary for the long-term commercial supply of
our product candidates, and next generation manufacturing
processes to reduce labor, drive down cost of goods and
improve manufacturing efficiencies.
We have made significant progress across many fronts during
the year, have gained immeasurably through adversity, and
have laid a solid foundation which sets us up for success
for this year and beyond. I am excited about the upcoming
milestones that stretch across the portfolio and the strategic
possibilities that come with achieving success on these fronts.
I would like to thank the whole Mesoblast team for the
wonderful dedication and immense knowledge and skills
that each of them brings to the organization. I know that the
Mesoblast people strive for success, not merely for themselves,
but because we all want to be part of solutions that save lives,
particularly those of children. I would also like to acknowledge
the support of our Board and stakeholders, most importantly
the patients, the healthcare professionals who look after them,
and our shareholders, who I know are also just as passionate
about finding therapies for these critical unmet needs.
Yours sincerely,
Dr Silviu Itescu
Chief Executive
MESOBLAST LIMITED 2021 ANNUAL REPORT 3
FORM
20-F
4 MESOBLAST LIMITED 2021 ANNUAL REPORT
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 20-F
☐
☒
☐
☐
REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
For the fiscal year ended June 30, 2021
OR
Date of event requiring this shell company report
For the transition period from to
Commission file number 001-37626
MESOBLAST LIMITED
(Exact name of Registrant as specified in its charter)
N/A
(Translation of Registrant’s name into English)
AUSTRALIA
(Jurisdiction of incorporation or organization)
Level 38, 55 Collins Street
Melbourne, VIC, 3000, Australia
Telephone: +61 (3) 9639 6036
(Address of principal executive offices)
Silviu Itescu
Chief Executive Officer
Telephone: +61 (3) 9639 6036; Fax: +61 (3) 9639 6030
Level 38, 55 Collins Street
Melbourne, VIC, 3000, Australia
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b) of the Act.
Trading Symbol(s)
MESO
Title of each class
American Depositary Shares, each representing five Ordinary Shares*
Name of each exchange on which registered
The NASDAQ Global Select Market
Securities registered or to be registered pursuant to Section 12(g) of the Act.
None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.
None
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
648,696,070 Ordinary Shares
☒ Yes ☐ No
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of
this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
☒ Yes ☐ No
☐ Yes ☒ No
☒ Yes ☐ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer, or an emerging growth company. See definition of “large
accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer
Accelerated filer
☐
☐
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended
Non-accelerated filer
Emerging growth company
☐
☒
transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting
under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
☒
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
International Financial Reporting Standards as issued by the International
Accounting Standards Board
☐
☒
U.S. GAAP
Other
☐
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Item 17 ☐ Item 18 ☐
☐ Yes ☒ No
Table of Contents
INTRODUCTION AND USE OF CERTAIN TERMS ...............................................................................................................
FORWARD-LOOKING STATEMENTS....................................................................................................................................
PART I..........................................................................................................................................................................................
Item 1.
Identity of Directors, Senior Management.....................................................................................................
Item 2. Offer Statistics and Expected Timetable........................................................................................................
Item 3. Key Information.............................................................................................................................................
3.A Selected Financial Data..................................................................................................................................
3.B Capitalization and Indebtedness ....................................................................................................................
3.C Reasons for the offer and use of proceeds .....................................................................................................
3.D Risk Factors ...................................................................................................................................................
Item 4.
Information on the Company .........................................................................................................................
4.A History and Development of Mesoblast ........................................................................................................
4.B Business Overview.........................................................................................................................................
4.C Organizational Structure ................................................................................................................................
4.D Property, Plants and Equipment.....................................................................................................................
Item 4A. Unresolved Staff Comments ..........................................................................................................................
Item 5. Operating and Financial Review and Prospects.............................................................................................
5.A Operating Results...........................................................................................................................................
5.B Liquidity and Capital Resources....................................................................................................................
5.C Research and Development, Patents and Licenses ........................................................................................
5.D Trend Information..........................................................................................................................................
5.E Critical Accounting Estimates .......................................................................................................................
Item 6. Directors, Senior Management and Employees.............................................................................................
6.A Directors and Senior Management.................................................................................................................
6.B Compensation ................................................................................................................................................
6.C Board Practices ..............................................................................................................................................
6.D Employees......................................................................................................................................................
6.E Share Ownership............................................................................................................................................
Item 7. Major Shareholders and Related Party Transactions .....................................................................................
7.A Major Shareholders........................................................................................................................................
7.B Related Party Transactions ............................................................................................................................
7.C Interests of Experts and Counsel....................................................................................................................
Item 8. Financial Information.....................................................................................................................................
8.A Consolidated Statements and Other Financial Information ...........................................................................
8.B Significant Changes .......................................................................................................................................
Item 9. The Offer and Listing.....................................................................................................................................
9.A Offer and Listing Details ...............................................................................................................................
9.B Plan of Distribution........................................................................................................................................
9.C Markets ..........................................................................................................................................................
9.D Selling Shareholders ......................................................................................................................................
9.E Dilution ..........................................................................................................................................................
9.F Expenses of the Issue .....................................................................................................................................
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Item 10. Additional Information ..................................................................................................................................
10.A Share Capital..................................................................................................................................................
10.B Memorandum and Articles of Association ....................................................................................................
10.C Material Contracts..........................................................................................................................................
10.D Exchange Controls .........................................................................................................................................
10.E Taxation .........................................................................................................................................................
10.F Dividends and Paying Agents........................................................................................................................
10.G Statement by Experts .....................................................................................................................................
10.H Documents on Display...................................................................................................................................
10.I Subsidiary Information ..................................................................................................................................
Item 11. Quantitative and Qualitative Disclosures about Market Risk........................................................................
Item 12. Description of Securities Other than Equity Securities .................................................................................
12.A Debt Securities ...............................................................................................................................................
12.B Warrants and Rights.......................................................................................................................................
12.C Other Securities..............................................................................................................................................
12.D American Depositary Shares..........................................................................................................................
PART II ........................................................................................................................................................................................
Item 13. Defaults, Dividend Arrearages and Delinquencies........................................................................................
Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds ...........................................
Item 15. Controls and Procedures ................................................................................................................................
Item 16A. Audit Committee Financial Expert ................................................................................................................
Item 16B. Code of Ethics................................................................................................................................................
Item 16C. Principal Accountant Fees and Services ........................................................................................................
Item 16D. Exemptions from the Listing Standards for Audit Committees.....................................................................
Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers........................................................
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Item 16F. Change in Registrant’s Certifying Accountant ..............................................................................................
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Item 16G. Corporate Governance ...................................................................................................................................
Item 16H. Mine Safety Disclosure..................................................................................................................................
PART III .......................................................................................................................................................................................
Item 17. Financial Statements ......................................................................................................................................
Item 18. Financial Statements ......................................................................................................................................
Item 19. Exhibits ..........................................................................................................................................................
SIGNATURES .............................................................................................................................................................................
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INTRODUCTION AND USE OF CERTAIN TERMS
Mesoblast Limited and its consolidated subsidiaries publish consolidated financial statements expressed in U.S. dollars, unless
otherwise indicated. This Annual Report on Form 20-F is presented in U.S. dollars, unless otherwise indicated. Our consolidated
financial statements found in Item 18 of this annual report on Form 20-F are prepared in accordance with International Financial
Reporting Standards as issued by the International Accounting Standards Board and Australian equivalents to International Financial
Reporting Standards as issued by the Australian Accounting Standards Board.
Except where the context requires otherwise and for purposes of this Form 20-F only:
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“ADSs” refers to our American depositary shares, each of which represents ordinary shares, and “ADRs” refers to the
American depositary receipts that evidence our ADSs.
“Mesoblast,” “we,” “us” or “our” refer to Mesoblast Limited and its subsidiaries.
“A$” or “Australian dollar” refers to the legal currency of Australia.
“AIFRS” refers to the Australian equivalents to International Financial Reporting Standards as issued by the Australian
Accounting Standards Board, or AASB.
“CHF” refers to the legal currency of Switzerland.
“FDA” refers to the United States Food and Drug Administration.
“GBP” refers to the legal currency of the United Kingdom.
“IFRS” refers to the International Financial Reporting Standards as issued by the International Accounting Standards
Board, or IASB.
“S$” or “SGD” or “Singapore dollar” refers to the legal currency of Singapore.
“U.S. GAAP” refers to the Generally Accepted Accounting Principles in the United States.
“US$” or “U.S. dollars” refers to the legal currency of the United States.
“U.S.” or “United States” refers to the United States of America.
“€” or “Euro” refers to the legal currency of the European Union.
Australian Disclosure Requirements
Our ordinary shares are primarily quoted on the Australian Securities Exchange (“ASX”) in addition to our listing of our ADSs
on the Nasdaq Global Select Market. As part of our ASX listing, we are required to comply with various disclosure requirements as
set out under the Australian Corporations Act 2001 and the ASX Listing Rules. Information furnished under the sub-heading
“Australian Disclosure Requirements” is intended to comply with ASX listing and Corporations Act 2001 disclosure requirements and
is not intended to fulfill information required by this Annual Report on Form 20-F.
2
FORWARD-LOOKING STATEMENTS
This Form 20-F includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on our current expectations,
assumptions, estimates and projections about the Company, our industry, economic conditions in the markets in which we operate, and
certain other matters. These statements include, among other things, the discussions of our business strategy and expectations
concerning our market position, future operations, margins, profitability, liquidity and capital resources. These statements are subject
to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or
achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by
these forward-looking statements. Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,”
“target,” “likely,” “will,” “would,” “could,” “should”, “may”, “goal,” “objective” and similar expressions or phrases identify forward-
looking statements. We have based these forward-looking statements largely on our current expectations and future events and
financial trends that we believe may affect our financial condition, results of operation, business strategy and financial needs.
Forward- looking statements include, but are not limited to, statements about:
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the initiation, timing, progress and results of our preclinical and clinical studies, and our research and development
programs;
our ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national
clinical trials;
our ability to advance our manufacturing capabilities;
the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if
any;
our ability to take advantage of the potential benefits of the 21st Century Cures Act;
the impact that the COVID-19 pandemic could have on business operations;
the commercialization of our product candidates, if approved;
regulatory or public perceptions and market acceptance surrounding the use of cell based therapies;
the potential for our product candidates, if any are approved, to be withdrawn from the market due to patient adverse
events or deaths;
the potential benefits of strategic collaboration agreements and our ability to enter into and maintain established strategic
collaborations;
our ability to establish and maintain intellectual property on our product candidates and our ability to successfully defend
these in cases of alleged infringement;
the scope of protection we are able to establish and maintain for intellectual property rights covering our product
candidates and technology;
our ability to obtain additional financing;
estimates of our expenses, future revenues, capital requirements and our needs for additional financing;
our financial performance;
developments relating to our competitors and our industry;
the pricing and reimbursement of our product candidates, if approved; and
other risks and uncertainties, including those listed under the caption “Risk Factors”.
You should read thoroughly this Form 20-F and the documents that we refer to herein with the understanding that our actual
future results may be materially different from and/or worse than what we expect. We qualify all of our forward-looking statements by
these cautionary statements. Other sections of this Form 20-F include additional factors which could adversely impact our business
and financial performance. Moreover, we operate in an evolving environment. New risk factors emerge from time to time and it is not
possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to
which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking
statements.
3
This Form 20-F also contains third-party data relating to the biopharmaceutical market that includes projections based on a
number of assumptions. The biopharmaceutical market may not grow at the rates projected by market data, or at all. The failure of this
market to grow at the projected rates may have a material adverse effect on our business and the market price of our ordinary shares
and ADSs. Furthermore, if any one or more of the assumptions underlying the market data turns out to be incorrect, actual results may
differ from the projections based on these assumptions. You should not place undue reliance on these forward-looking statements.
You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in
this Form 20-F relate only to events or information as of the date on which the statements are made in this Form 20-F. We undertake
no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
4
PART I
Item 1.
Identity of Directors, Senior Management
Not applicable.
Item 2.
Offer Statistics and Expected Timetable
Not applicable.
Item 3.
Key Information
3.A
Selected Financial Data
Not applicable.
3.B
Capitalization and Indebtedness
Not applicable.
3.C
Reasons for the offer and use of proceeds
Not applicable.
3.D
Risk Factors
You should carefully consider the risks described below and all other information contained in this Annual Report on Form 20-F
before making an investment decision. If any of the following risks actually occur, our business, financial condition and results of
operations could be materially and adversely affected. In that event, the trading price of our ordinary shares and ADSs could decline,
and you may lose part or all of your investment. This Annual Report on Form 20-F also contains forward-looking information that
involves risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements
as a result of many factors, including the risks described below and elsewhere in this Annual Report on Form 20-F.
Risks Related to Our Financial Position and Capital Requirements
We have incurred operating losses since our inception and anticipate that we will continue to incur substantial operating losses for
the foreseeable future. We may never achieve or sustain profitability.
We are a clinical-stage biotechnology company and we have not yet generated significant revenues. We have incurred net losses
during most of our fiscal periods since our inception. Our net loss for the year ended June 30, 2021 was $98.8 million. As of June 30,
2021, we have an accumulated deficit of $647.6 million since our inception. We do not know whether or when we will become
profitable. Our losses have resulted principally from costs incurred in clinical development and manufacturing activities.
We anticipate that our expenses will increase as we move toward commercialization, including the scaling up of our
manufacturing activities and our establishment of infrastructure and logistics necessary to support potential product launches.
Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. To achieve and
maintain profitability, we must successfully develop our product candidates, obtain regulatory approval, and manufacture, market and
sell those products for which we obtain regulatory approval. If we obtain regulatory approval to market a product candidate, our future
revenue will depend upon the size of any markets in which our product candidates may receive approval, and our ability to achieve
and maintain sufficient market acceptance, pricing, reimbursement from third-party payors, and adequate market share for our product
candidates in those markets. We may not succeed in these activities, and we may never generate revenue from product sales that is
significant enough to achieve profitability. Our failure to become or remain profitable would depress our market value and could
impair our ability to raise capital, expand our business, discover or develop other product candidates or continue our operations. A
decline in the value of our company could cause you to lose part or all of your investment.
We have never generated revenue from product sales and may never be profitable.
Our ability to generate revenue and achieve profitability depends on our ability, either alone or with strategic collaboration
partners, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, our product
candidates. We do not currently generate revenues from product sales (other than licensing revenue from sales of TEMCELL® HS.
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Inj. (“TEMCELL”), a registered trademark of JCR Pharmaceuticals Co., Ltd. (“JCR”), by JCR in Japan, and royalty revenue from net
sales of Alofisel® a registered trademark of TiGenix NV (“TiGenix”), previously known as Cx601, an adipose-derived mesenchymal
stromal cell product developed by TiGenix, now a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (“Takeda”)
and approved for marketing in the EU), and we may never generate product sales. Our ability to generate future revenues from product
sales depends heavily on our success in a number of areas, including:
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completing research, preclinical and clinical development of our product candidates;
seeking and obtaining regulatory and marketing approvals for product candidates for which we complete clinical studies;
establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate (in
amount and quality) products and services to support clinical development and the market demand for our product
candidates, if approved;
launching and commercializing product candidates for which we obtain regulatory and marketing approval, either by
collaborating with a partner or, if launched independently, by establishing commercial and distribution capabilities
necessary to effectively seek and maintain market access and ensure compliance with legal and regulatory requirements
relating to interactions with healthcare providers, healthcare organizations and government agencies;
obtaining market acceptance of our product candidates as viable treatment options;
addressing competing technological and market developments;
obtaining and sustaining an adequate level of reimbursement from payors;
identifying and validating new cell therapy product candidates;
negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter;
maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets, know-
how and trademarks;
attracting, hiring and retaining qualified personnel; and
implementing additional internal systems and infrastructure, as needed.
Even if one or more of the product candidates that we develop is approved for commercial sale, we anticipate incurring
significant costs associated with commercializing and distributing any approved product candidate. Our expenses could increase
beyond expectations if we are required by the United States Food and Drug Administration (“FDA”), the European Medicines Agency
(“EMA”), or other regulatory agencies, to perform clinical and other studies in addition to those that we currently anticipate. We may
not become profitable and may need to obtain additional funding to continue operations.
We require substantial additional financing to achieve our goals, and our failure to obtain this necessary capital or establish and
maintain strategic partnerships to provide funding support for our development programs could force us to delay, limit, reduce or
terminate our product development or commercialization efforts.
Our operations have consumed substantial amounts of cash since inception. As of June 30, 2021, our cash and cash equivalents
were $136.9 million. We expect to continue to incur significant expenses and increase our cumulative operating losses for the
foreseeable future in connection with our planned research, development and product commercialization efforts. In addition, we will
require additional financing to achieve our goals and our failure to do so could adversely affect our commercialization efforts. We
anticipate that our expenses will increase if and as we:
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continue the research and clinical development of our product candidates, including MPC-150-IM (Class II-IV Chronic
Heart Failure (“CHF”)), MPC-06-ID (Chronic Low Back Pain (“CLBP”)), remestemcel-L and MPC-300-IV
(inflammatory conditions) product candidates;
seek to identify, assess, acquire, and/or develop other and combination product candidates and technologies;
seek regulatory and marketing approvals in multiple jurisdictions for our product candidates that successfully complete
clinical studies and
to facilitate development and ultimate
commercialization of our products;
identify and apply for regulatory designations
establish and maintain collaborations and strategic partnerships with third parties for the development and
commercialization of our product candidates, or otherwise build and maintain a sales, marketing and distribution
infrastructure and/or external logistics to commercialize any products for which we may obtain marketing approval;
further develop and implement our proprietary manufacturing processes in both planar technology and our bioreactor
programs and expand our manufacturing capabilities and resources for commercial production;
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seek coverage and reimbursement from third-party payors, including government and private payors for future products;
make milestone or other payments under our agreements pursuant to which we have licensed or acquired rights to
intellectual property and technology;
seek to maintain, protect and expand our intellectual property portfolio;
seek to attract and retain skilled personnel; and
develop the compliance and other infrastructure necessary to support product commercialization and distribution.
If we were to experience any delays or encounter issues with any of the above, including clinical holds, failed studies,
inconclusive or complex results, safety or efficacy issues, or other regulatory challenges that require longer follow-up of existing
studies, additional studies, or additional supportive studies in order to pursue marketing approval, it could further increase the costs
associated with the above. Further, the net operating losses we incur may fluctuate significantly from quarter to quarter and year to
year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest
may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a
shareholder or as a holder of the ADSs. Debt financing, if available, may involve agreements that include covenants limiting or
restricting our ability to take certain actions, such as incurring additional debt, making capital expenditures or declaring dividends. If
we raise additional funds through strategic collaborations or partnerships, or marketing, distribution or licensing arrangements with
third parties, we may be required to do so at an earlier stage than would otherwise be ideal and/or may have to limit valuable rights to
our intellectual property, technologies, product candidates or future revenue streams, or grant licenses or other rights on terms that are
not favorable to us. Furthermore, any additional fundraising efforts may divert our management from their day-to-day activities, which
may adversely affect our ability to develop and commercialize our product candidates.
The terms of our loan facilities with Hercules Capital, Inc. (“Hercules”) and NovaQuest Capital Management, L.L.C.
(“NovaQuest”) could restrict our operations, particularly our ability to respond to changes in our business or to take specified
actions.
On March 6, 2018, we entered into a loan and security agreement with Hercules, for a $75.0 million non-dilutive, four-year
credit facility. We drew the first tranche of $35.0 million at closing, and we have subsequently drawn a further $15.0 million. On June
29, 2018, we entered into a loan and security agreement with NovaQuest for a $40.0 million non-dilutive, eight-year term credit
facility, repayable from net sales of our allogeneic product candidate remestemcel-L in pediatric patients with steroid-refractory acute
graft versus host disease (“SR-aGVHD”), in the United States and other geographies excluding Asia. We drew the first tranche of
$30.0 million on closing. Our loan facilities with Hercules and NovaQuest contain a number of covenants that impose operating
restrictions on us, which may restrict our ability to respond to changes in our business or take specified actions. The Group has an
operating objective to at all times maintain unrestricted cash reserves in excess of six months liquidity. This objective aligns with our
loan and security agreement with Hercules where we are obliged to maintain certain levels of cash in the United States, and a
minimum unrestricted cash balance equal to the lessor of: four months liquidity (defined as the prior four calendar months net cash
outflows in operating activities and investing activities, excluding amounts for extraordinary, non-recurring, not regularly scheduled or
onetime proceeds and amounts) plus any balance of accounts payable not paid after the 120th day following the invoice date for such
accounts payable; and the outstanding loan balance. Our ability to comply with the various covenants under the agreements may be
affected by events beyond our control, and we may not be able to continue to meet the covenants. Upon the occurrence of an event of
default, Hercules or NovaQuest could elect to declare all amounts outstanding under the loan facility to be immediately due and
payable and terminate all commitments to extend further credit. If Hercules or NovaQuest accelerates the repayment, if any, we may
not have sufficient funds to repay our existing debt. In addition, in August 2021, we entered into a contractual arrangement with
Hercules that extended the interest-only period of the Hercules debt facility to January 1, 2022. Accordingly, as from that date, we are
expected to repay the principal amount drawn under such debt facility through to facility expiry in March 2022. Although we intend to
refinance this debt, we may not be successful in obtaining refinancing terms that are acceptable. If we were unable to repay the owed
amounts, Hercules or NovaQuest could proceed against the collateral granted to it to secure such indebtedness. We have pledged
substantially all of our assets as collateral under the loan facility with Hercules, and a portion of our assets relating to the SR-aGVHD
product candidate as collateral under the loan facility with NovaQuest.
We are subject to risks associated with currency fluctuations, and changes in foreign currency exchange rates could impact our
results of operations.
Historically, a substantial portion of our operating expenses has been denominated in U.S. dollars and our main currency
requirements are U.S. dollars, Australian dollars and Singapore dollars. Approximately 89% of our cash and cash equivalents as of
June 30, 2021 were denominated in U.S. dollars and 11% were denominated in Australian dollars. Because we have multiple
functional currencies across different jurisdictions, changes in the exchange rate between these currencies and the foreign currencies
of the transactions recorded in our accounts could materially impact our reported results of operations and distort period-to-period
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comparisons. For example, a portion of our research and clinical trials are undertaken in Australia. As such, payment will be made in
Australian dollar currency, and may exceed the budgeted expenditure if there are adverse currency fluctuations against the U.S. dollar.
More specifically, if we decide to convert our Australian dollars into U.S. dollars for any business purpose, appreciation of the
U.S. dollar against the Australian dollar would have a negative effect on the U.S. dollar amount available to us. Appreciation or
depreciation in the value of the Australian dollar relative to the U.S. dollar would affect our financial results reported in U.S. dollar
terms without giving effect to any underlying change in our business or results of operations. As a result of such foreign currency
fluctuations, it could be more difficult to detect underlying trends in our business and results of operations.
Unfavorable global economic or political conditions could adversely affect our business, financial condition or results of
operations.
Our results of operations could be adversely affected by general conditions in the global economy and in the global financial
markets. A global financial crisis or a global or regional political disruption could cause extreme volatility in the capital and credit
markets. A severe or prolonged economic downturn or political disruption could result in a variety of risks to our business, including
weakened demand for our product candidates, if approved, and our ability to raise additional capital when needed on acceptable terms,
if at all. A weak or declining economy or political disruption could also strain our manufacturers or suppliers, possibly resulting in
supply disruption. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the political or
economic climate and financial market conditions could adversely impact our business.
Risks Related to Clinical Development and Regulatory Review and Approval of Our Product Candidates
Our product candidates are based on our novel mesenchymal lineage cell technology, which makes it difficult to accurately and
reliably predict the time and cost of product development and subsequently obtaining regulatory approval. At the moment, no
industrially manufactured, non-hematopoietic, allogeneic cell products have been approved in the United States.
Other than with respect to sales of products by our licensees, we have not commercially marketed, distributed or sold any
products. The success of our business depends on our ability to develop and commercialize our lead product candidates. We have
concentrated our product research and development efforts on our mesenchymal lineage cell platform, a novel type of cell therapy.
Our future success depends on the successful development of this therapeutic approach. There can be no assurance that any
development problems we experience in the future related to our mesenchymal lineage cell platform will not cause significant delays
or unanticipated costs, or that such development problems can be solved. We may also experience delays in developing sustainable,
reproducible and scalable manufacturing processes or transferring these processes to collaborators, which may prevent us from
completing our clinical studies or commercializing our products on a timely or profitable basis, if at all.
In addition, the clinical study requirements of the FDA, the EMA and other regulatory agencies and the criteria these regulators
use to determine the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and
intended use and market of the potential product candidates. The regulatory approval process for novel product candidates such as
ours can be more expensive and take longer to develop than for other, better known or extensively studied pharmaceutical or other
product candidates. In addition, adverse developments in clinical trials of cell therapy products conducted by others may cause the
FDA or other regulatory bodies to change the requirements for approval of any of our product candidates.
We may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory agencies.
We must conduct extensive testing of our product candidates to demonstrate their safety and efficacy, including both preclinical
animal testing and evaluation in human clinical trials, before we can obtain regulatory approval to market and sell them. Conducting
such testing is a lengthy, time-consuming, and expensive process and there is a high rate of failure.
Our current and completed preclinical and clinical results for our product candidates are not necessarily predictive of the results
of our ongoing or future clinical trials. Promising results in preclinical studies of a product candidate may not be predictive of similar
results in humans during clinical trials, and successful results from early human clinical trials of a product candidate may not be
replicated in later and larger human clinical trials or in clinical trials for different indications. If the results of our or our collaborators’
ongoing or future clinical trials are negative or inconclusive with respect to the efficacy of our product candidates, or if these trials do
not meet the clinical endpoints with statistical significance, or if there are safety concerns or adverse events associated with our
product candidates, we or our collaborators may be prevented or delayed in obtaining marketing approval for our product candidates.
Even if ongoing or future clinical studies meet the clinical endpoints with statistical significance, the FDA or other regulatory
agencies may still find the data insufficient to support marketing approval based on other factors.
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We may encounter substantial delays in our clinical studies, including as a result of the COVID-19 pandemic.
We cannot guarantee that any preclinical testing or clinical trials will be conducted as planned or completed on schedule, if at
all. As a result, we may not achieve our expected clinical milestones. A failure can occur at any stage of testing. Events that may
prevent successful or timely commencement, enrollment or completion of clinical development include:
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problems which may arise as a result of our transition of research and development programs from licensors or previous
sponsors;
delays in raising, or inability to raise, sufficient capital to fund the planned trials;
delays by us or our collaborators in reaching a consensus with regulatory agencies on trial design;
changes in trial design;
inability to identify, recruit and train suitable clinical investigators;
inability to add new clinical trial sites;
delays in reaching agreement on acceptable terms for the performance of the trials with contract research organizations
(“CROs”), and clinical trial sites;
delays in obtaining required Institutional Review Board (“IRB”), approval at each clinical trial site;
delays in recruiting suitable clinical sites and patients (i.e., subjects) to participate in clinical trials and delays in accruing
medical events necessary to complete any events-driven trial;
imposition of a clinical hold by regulatory agencies for any reason, including negative clinical results, safety concerns or
as a result of an inspection of manufacturing or clinical operations or trial sites;
failure by CROs, other third parties or us or our collaborators to adhere to clinical trial requirements;
failure to perform in accordance with the FDA’s current Good Clinical Practices (“cGCP”), or applicable regulatory
guidelines in other countries;
delays in testing, validation, manufacturing and delivery of a product candidate to clinical trial sites;
delays caused by patients not completing participation in a trial or not returning for post-treatment follow-up;
delays caused by clinical trial sites not completing a trial;
failure to demonstrate adequate efficacy;
occurrence of serious adverse events in clinical trials that are associated with a product candidates and that are viewed to
outweigh its potential benefits;
changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; or
disagreements between us and the FDA or other regulatory agencies regarding a clinical trial design, protocol
amendments, or interpreting the data from our clinical trials.
In addition, our ongoing clinical trials may be affected by delays in monitoring and data collection as a result of the COVID-19
pandemic, including due to prioritization of hospital resources, travel restrictions, and the inability to access sites for patient
monitoring. In addition, some patients may be unable to comply with clinical trial protocols if quarantines or stay at home orders
impede patient movement or interrupt health services.
Delays, including delays caused by the above factors, can be costly and could negatively affect our or our collaborators’ ability
to complete clinical trials for our product candidates. If we or our collaborators are not able to successfully complete clinical trials or
are not able to do so in a timely and cost-effective manner, we will not be able to obtain regulatory approval and/or will not be able to
commercialize our product candidates and our commercial partnering opportunities will be harmed.
We may find it difficult to enroll patients in our clinical trials, which could delay or prevent development of our product
candidates.
Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing
of our clinical trials depends on the speed at which we can recruit patients to participate in testing our product candidates as well as
completion of required follow-up periods. In general, if patients are unwilling to participate in our cell therapy trials because of
negative publicity from adverse events in the biotechnology or cell therapy industries or for other reasons, including competitive
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clinical trials for similar patient populations, the timeline for recruiting patients, conducting trials and obtaining regulatory approval
for our product candidates may be delayed. Additionally, we or our collaborators generally will have to run multi-site and potentially
multi-national trials, which can be time consuming, expensive and require close coordination and supervision. If we have difficulty
enrolling a sufficient number of patients or otherwise conducting clinical trials as planned, we or our collaborators may need to delay,
limit or terminate ongoing or planned clinical trials, any of which would have an adverse effect on our business.
If there are delays in accumulating the required number of trial subjects or, in trials where clinical events are a primary endpoint,
if the events needed to assess performance of our clinical candidates do not accrue at the anticipated rate, there may be delays in
completing the trial. These delays could result in increased costs, delays in advancing development of our product candidates,
including delays in testing the effectiveness, or even termination of the clinical trials altogether.
Patient enrollment and completion of clinical trials are affected by factors including:
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size of the patient population, particularly in orphan diseases;
severity of the disease under investigation;
design of the trial protocol;
eligibility criteria for the particular trial;
perceived risks and benefits of the product candidate being tested;
proximity and availability of clinical trial sites for prospective patients;
availability of competing therapies and clinical trials;
efforts to facilitate timely enrollment in clinical trials;
patient referral practices of physicians and level and effectiveness of study site recruitment efforts; and
ability to monitor patients adequately during and after treatment.
Once enrolled, patients may choose to discontinue their participation at any time during the trial, for any reason. Participants
also may be terminated from the study at the initiative of the investigator, for example if they experience serious adverse clinical
events or do not follow the study directions. If we are unable to maintain an adequate number of patients in our clinical trials, we may
be required to delay or terminate an ongoing clinical trial, which would have an adverse effect on our business.
We may conduct multinational clinical trials, which present additional and unique risks.
We plan to seek initial marketing approval for our product candidates in the United States and in select non-U.S. jurisdictions
such as Europe, Japan and Canada. Conducting trials on a multinational basis requires collaboration with foreign medical institutions
and healthcare providers. Our ability to successfully initiate, enroll and complete a clinical trial in multiple countries is subject to
numerous risks unique to conducting business internationally, including:
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difficulty in establishing or managing relationships with physicians, sites and CROs;
standards within different jurisdictions for conducting clinical trials and recruiting patients;
our ability to effectively interface with non-US regulatory authorities;
our inability to identify or reach acceptable agreements with qualified local consultants, physicians and partners;
the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements,
including the regulation of pharmaceutical and biotechnology products and treatments, and anti-corruption/anti-bribery
laws;
differing genotypes, average body weights and other patient profiles within and across countries from our donor profile
may impact the optimal dosing or may otherwise impact the results of our clinical trials; and
the COVID-19 pandemic limiting our ability to commence and conduct studies, including recruiting patients.
The complexity of conducting multinational clinical trials could negatively affect our or our collaborators’ ability to complete
trials as intended which could have an adverse effect on our business.
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Serious adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of our
product candidates, or limit the scope of any approved indication or market acceptance.
Participants in clinical trials of our investigational cell therapy products may experience adverse reactions or other undesirable
side effects. While some of these can be anticipated, others may be unexpected. We cannot predict the frequency, duration, or severity
of adverse reactions or undesirable side effects that may occur during clinical investigation of our product candidates. If any of our
product candidates, prior to or after any approval for commercial sale, cause serious adverse events or are associated with other safety
risks, a number of potentially significant negative consequences could result, including:
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regulatory authorities may suspend (e.g., through a clinical hold) or terminate clinical trials;
regulatory authorities may deny regulatory approval of our product candidates;
regulators may restrict the indications or patient populations for which a product candidate is approved;
regulatory authorities may require certain labeling statements, such as warnings or contraindications or limitations on the
indications for use, and/or impose restrictions on distribution in the form of a risk evaluation and mitigation strategy
(“REMS”), in connection with approval, if any;
regulatory authorities may withdraw their approval, require more onerous labeling statements or impose a more restrictive
REMS than any product that is approved;
we may be required to change the way the product is administered or conduct additional clinical trials;
patient recruitment into our clinical trials may suffer;
our relationships with our collaborators may suffer;
we could be required to provide compensation to subjects for their injuries, e.g., if we are sued and found to be liable or if
required by the laws of the relevant jurisdiction or by the policies of the clinical site; or
our reputation may suffer.
There can be no assurance that adverse events associated with our product candidates will not be observed, in such settings
where no prior adverse events have occurred. As is typical in clinical development, we have a program of ongoing toxicology studies
in animals for our clinical-stage product candidates and cannot provide assurance that the findings from such studies or any ongoing or
future clinical trials will not adversely affect our clinical development activities.
We may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to
participants or if preliminary data demonstrate that our product candidates are unlikely to receive regulatory approval or unlikely to be
successfully commercialized. In addition, regulatory agencies, IRBs or data safety monitoring boards may at any time recommend the
temporary or permanent discontinuation of our clinical trials or request that we cease using investigators in the clinical trials if they
believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements, or that they present an
unacceptable safety risk to participants. If we elect or are forced to suspend or terminate a clinical trial for any of our product
candidates, the commercial prospects for that product as well as our other product candidates may be harmed and our ability to
generate product revenue from these product candidates may be delayed or eliminated. Furthermore, any of these events could prevent
us or our collaborators from achieving or maintaining market acceptance of the affected product and could substantially increase the
costs of commercializing our product candidates and impair our ability to generate revenue from the commercialization of these
product candidates either by us or by our collaborators.
Several of our product candidates are being evaluated for the treatment of patients who are extremely ill, and patient deaths that
occur in our clinical trials could negatively impact our business even if they are not shown to be related to our product candidates.
We are developing MPC-150-IM, which will focus on Class II-IV CHF, and remestemcel-L, which will focus on SR-aGVHD.
We have also been developing remestemcel-L in COVID-19 infected patients with moderate to severe acute respiratory distress
syndrome (“ARDS”) on ventilator support. The patients who receive our product candidates are very ill due to their underlying
diseases.
Generally, patients remain at high risk following their treatment with our product candidates and may more easily acquire
infections or other common complications during the treatment period, which can be serious and life threatening. As a result, it is
likely that we will observe severe adverse outcomes in patients during our Phase 3 and other trials for these product candidates,
including patient death. If a significant number of study subject deaths were to occur, regardless of whether such deaths are
attributable to our product candidates, our ability to obtain regulatory approval for the applicable product candidate may be adversely
impacted and our business could be materially harmed. Should studies of a candidate product result in regulatory approval, any
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association with a significant number of study subject deaths could limit the commercial potential of an approved product candidate,
or negatively impact the medical community’s willingness to use our product with patients.
The requirements to obtain regulatory approval of the FDA and regulators in other jurisdictions can be costly, time-consuming,
and unpredictable. If we or our collaborators are unable to obtain timely regulatory approval for our product candidates, our
business may be substantially harmed.
The regulatory approval process is expensive and the time and resources required to obtain approval from the FDA or other
regulatory authorities in other jurisdictions to sell any product candidate is uncertain and approval may take years. Whether regulatory
approval will be granted is unpredictable and depends upon numerous factors, including the discretion of the regulatory authorities.
For example, governing legislation, approval policies, regulations, regulatory policies, or the type and amount of preclinical and
clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary
among jurisdictions. It is possible that none of our existing or future product candidates will ever obtain regulatory approval, even if
we expend substantial time and resources seeking such approval.
Further, regulatory requirements governing cell therapy products in particular have changed and may continue to change in the
future. For example, in December 2016, the 21st Century Cures Act (“Cures Act”) was signed into law in the United States. This law is
designed to advance medical innovation, and includes a number of provisions that may impact our product development programs. For
example, the Cures Act establishes a new “regenerative medicine advanced therapy” designation (“RMAT”), and creates a pathway
for increased interaction with FDA for the development of products which obtain designations. Although the FDA has issued guidance
documents in 2018, it remains unclear how and when the FDA will fully implement all deliverables under the Cures Act.
Any regulatory review committees and advisory groups and any contemplated new guidelines may lengthen the regulatory
review process, require us to perform additional studies, increase our development costs, lead to changes in regulatory positions and
interpretations, delay or prevent approval and commercialization of our product candidates or lead to significant post-approval
limitations or restrictions. As we advance our product candidates, we will be required to consult with these regulatory and advisory
groups, and comply with applicable guidelines. If we fail to do so, we may be required to delay or discontinue development of our
product candidates. Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring a product
candidate to market could decrease our ability to generate sufficient revenue to maintain our business.
The FDA and other regulatory bodies globally have issued numerous guidances regarding the impact of the COVID-19
pandemic on their operations. For example, FDA inspectors are unable to travel or are limited in their ability to travel during the
pandemic due to border closures and various stay at home orders. After falling significantly behind in scheduled site inspections FDA
has issued guidance for alternative remote inspections or “Remote Interactive Evaluations”. In addition, requested meetings with FDA
are delayed by a minimum of 3 months while the public health crisis is in effect, due to the increased workload burden on agency
staff. These and other guidances applied during the pandemic have the potential to delay the development process for all of Mesoblast
candidates.
Our product candidates could fail to receive regulatory approval for many reasons, including the following:
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we may be unable to successfully complete our ongoing and future clinical trials of product candidates;
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we may be unable to demonstrate to the satisfaction of the FDA or other regulatory authorities that a product candidate is
safe, pure, and potent for any or all of a product candidate’s proposed indications;
we may be unable to demonstrate that a product candidate’s benefits outweigh the risk associated with the product
candidate;
the FDA or other regulatory authorities may disagree with the design or implementation of our clinical trials;
the results of clinical trials may not meet the level of statistical significance required by the FDA or other regulatory
authorities for approval;
the FDA or other regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical
trials;
a decision by the FDA, other regulatory authorities or us to suspend or terminate a clinical trial at any time;
the data collected from clinical trials of our product candidates may be inconclusive or may not be sufficient to support the
submission of a Biologics License Application (“BLA”), or other submission or to obtain regulatory approval in the
United States or elsewhere;
our third party manufacturers of supplies needed for manufacturing product candidates may fail to satisfy FDA or other
regulatory requirements and may not pass inspections that may be required by FDA or other regulatory authorities;
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the failure to comply with applicable regulatory requirements following approval of any of our product candidates may
result in the refusal by the FDA or similar foreign regulatory agency to approve a pending BLA or supplement to a BLA
submitted by us for other indications or new product candidates; and
the approval policies or regulations of the FDA or other regulatory authorities outside of the United States may
significantly change in a manner rendering our clinical data insufficient for approval.
We or our collaborators may gain regulatory approval for any of our product candidates in some but not all of the territories
available and any future approvals may be for some but not all of the target indications, limiting their commercial potential.
Regulatory requirements and timing of product approvals vary from country to country and some jurisdictions may require additional
testing beyond what is required to obtain FDA approval. Approval by the FDA does not ensure approval by regulatory authorities in
other countries or jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in
other countries or by the FDA. The foreign regulatory approval process may include all of the risks associated with obtaining FDA
approval.
Our drug candidates may not benefit from an expedited approval path for cellular medicines designated as Regenerative Medicine
Advanced Therapies (RMATs) under the 21st Century Cures Act.
On December 21, 2017, the FDA granted RMAT designation for our novel MPC therapy in the treatment of heart failure
patients with left ventricular systolic dysfunction and left ventricular assist devices. While the Cures Act offers several potential
benefits to drugs designated as RMATs, including eligibility for increased agency support and advice during development, priority
review on filing, a potential pathway for accelerated or full approval based on surrogate or intermediate endpoints, and the potential to
use patient registry data and other sources of real world evidence for post approval confirmatory studies, there is no assurance that any
of these potential benefits will either apply to any or all of our drug candidates or, if applicable, accelerate marketing approval. RMAT
designation does not change the evidentiary standards of safety and effectiveness needed for marketing approval.
Furthermore, there is no certainty as to whether any of our product candidates that have not yet received RMAT designation
under the Cures Act will receive such designation under the Cures Act. Designation as an RMAT is within the discretion of the FDA.
Accordingly, even if we believe one of our products or product candidates meets the criteria for RMAT designation, the FDA may
disagree. Additionally, for any product candidate that receives RMAT designation, we may not experience a faster development,
review or approval process compared to conventional FDA procedures. The FDA may withdraw RMAT designation if it believes that
the product no longer meets the qualifying criteria for designation.
Even if we obtain regulatory approval for our product candidates, our products will be subject to ongoing regulatory scrutiny.
Any of our product candidates that are approved in the United States or in other jurisdictions will continue to be subject to
ongoing regulatory requirements relating to the quality, identity, strength, purity, safety, efficacy, testing, manufacturing, marketing,
advertising, promotion, distribution, sale, storage, packaging, pricing, import or export, record-keeping and submission of safety and
other post-market information for all approved product candidates. In the United States, this includes both federal and state
requirements. In particular, as a condition of approval of a BLA, the FDA may require a REMS, to ensure that the benefits of the drug
outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals and elements to
assure safe use (“ETASU”). ETASU can include, but are not limited to, special training or certification for prescribing or dispensing,
dispensing only under certain circumstances, special monitoring, and the use of patient registries. Moreover, regulatory approval may
require substantial post-approval (Phase 4) testing and surveillance to monitor the drug’s safety or efficacy. Delays in the REMS
approval process could result in delays in the BLA approval process. In addition, as part of the REMS, the FDA could require
significant restrictions, such as restrictions on the prescription, distribution and patient use of the product, which could significantly
impact our ability to effectively commercialize our product candidates, and dramatically reduce their market potential thereby
adversely impacting our business, results of operations and financial condition. Post-approval study requirements could add additional
burdens, and failure to timely complete such studies, or adverse findings from those studies, could adversely affect our ability to
continue marketing the product.
Any failure to comply with ongoing regulatory requirements, as well as post-approval discovery of previously unknown
problems, including adverse events of unanticipated severity or frequency, or with manufacturing operations or processes, may
significantly and adversely affect our ability to generate revenue from our product candidates, and may result in, among other things:
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restrictions on the marketing or manufacturing of the product candidates, withdrawal of the product candidates from the
market, or voluntary or mandatory product recalls;
suspension or withdrawal of regulatory approval;
costly regulatory inspections;
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fines, warning letters, or holds on clinical trials;
refusal by the FDA to approve pending applications or supplements to approved applications filed by us or our
collaborators, or suspension or revocation of BLAs;
restrictions on our operations;
product seizure or detention, or refusal to permit the import or export of products; or
injunctions or the imposition of civil or criminal penalties by FDA or other regulatory bodies.
If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our business and our operating results
will be adversely affected.
The FDA’s policies, or that of the applicable regulatory bodies in other jurisdictions, may change, and additional government
regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the
likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the
United States or abroad. If we or our collaborators are not able to maintain regulatory compliance, are slow or unable to adopt new
requirements or policies, or effect changes to existing requirements, we or our collaborators may no longer be able to lawfully market
our product, and we may not achieve or sustain profitability, which would adversely affect our business.
Ethical and other concerns surrounding the use of embryonic stem cell-based therapy may negatively affect regulatory approval or
public perception of our non-embryonic stem cell product candidates, which could reduce demand for our products or depress our
share price.
The use of embryonic stem cells (“ESCs”), for research and therapy has been the subject of considerable public debate, with
many people voicing ethical, legal and social concerns related to their collection and use. Our cells are not ESCs, which have been the
predominant focus of this public debate and concern in the United States and elsewhere. However, the distinction between ESCs and
non-ESCs, such as our mesenchymal lineage cells, may be misunderstood by the public. Negative public attitudes toward cell therapy
and publicity and harm from cell therapy usage clinically by others could also result in greater governmental regulation of cell
therapies, which could harm our business. The improper use of cells could give rise to ethical and social commentary adverse to us,
which could harm the market demand for new products and depress the price of our ordinary shares and ADSs. Ongoing lack of
understanding of the difference between ESCs and non-ESCs could negatively impact the public’s perception of our company and
product candidates and could negatively impact us.
Additional government-imposed restrictions on, or concerns regarding possible government regulation of, the use of cell
therapies in research, development and commercialization could also cause an adverse effect on us by harming our ability to establish
important partnerships or collaborations, delaying or preventing the development of certain product candidates, and causing a decrease
in the price of our ordinary shares and ADSs, or by otherwise making it more difficult for us to raise additional capital. For example,
concerns regarding such possible regulation could impact our ability to attract collaborators and investors. Also, existing and potential
government regulation of cell therapies may lead researchers to leave the field of cell therapy research altogether in order to assure
that their careers will not be impeded by restrictions on their work. This may make it difficult for us to find and retain qualified
scientific personnel.
Orphan drug designation may not ensure that we will benefit from market exclusivity in a particular market, and if we fail to
obtain or maintain orphan drug designation or other regulatory exclusivity for some of our product candidates, our competitive
position would be harmed.
A product candidate that receives orphan drug designation can benefit from potential commercial benefits following approval.
Under the Orphan Drug Act, the FDA may designate a product candidate as an orphan drug if it is intended to treat a rare disease or
condition, defined as affecting (1) a patient population of fewer than 200,000 in the United States, (2) a patient population greater than
200,000 in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales
in the United States, or (3) an “orphan subset” of a patient population greater than 200,000 in the United States. In the European Union
(“EU”), the EMA’s Committee for Orphan Medicinal Products grants orphan drug designation to promote the development of
products that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting
not more than 10,000 persons in the EU. Currently, this designation provides market exclusivity in the U.S. and the EU for seven
years and ten years, respectively, if a product is the first such product approved for such orphan indication. This market exclusivity
does not, however, pertain to indications other than those for which the drug was specifically designated in the approval, nor does it
prevent other types of drugs from receiving orphan designations or approvals in these same indications. Further, even after an orphan
drug is approved, the FDA can subsequently approve a drug with similar chemical structure for the same condition if the FDA
concludes that the new drug is clinically superior to the orphan product or a market shortage occurs. In the EU, orphan exclusivity
may be reduced to six years if the drug no longer satisfies the original designation criteria or can be lost altogether if the marketing
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authorization holder consents to a second orphan drug application or cannot supply enough drug, or when a second applicant
demonstrates its drug is “clinically superior” to the original orphan drug.
Our remestemcel-L product candidate has received orphan drug designation for the treatment of aGVHD by the FDA and EMA,
and our CHF product candidate, rexlemestrocel-L has received orphan drug designation from the FDA for prevention of post-
implantation mucosal bleeding in end-stage CHF patients who require a left ventricular assist device (“LVAD”). If we seek orphan
drug designations for other product candidates in other indications, we may fail to receive such orphan drug designations and, even if
we succeed, such orphan drug designations may fail to result in or maintain orphan drug exclusivity upon approval, which would harm
our competitive position.
We may face competition from biosimilars due to changes in the regulatory environment.
In the United States, the Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway for
biological products that are demonstrated to be “highly similar”, or biosimilar, to or “interchangeable” with an FDA-approved
innovator (original) biological product. This pathway could allow competitors to reference data from innovator biological products
already approved after 12 years from the time of approval. For several years the annual budget requests of President Obama’s
administration included proposals to cut this 12-year period of exclusivity down to seven years. Those proposals were not adopted by
Congress. Under President Biden’s administration, it is unclear if a similar change will be pursued in the future. In Europe, the
European Commission has granted marketing authorizations for several biosimilars pursuant to a set of general and product class-
specific guidelines for biosimilar approvals issued over the past few years. In Europe, a competitor may reference data from biological
products already approved, but will not be able to get on the market until ten years after the time of approval. This 10-year period will
be extended to 11 years if, during the first eight of those 10 years, the marketing authorization holder obtains an approval for one or
more new therapeutic indications that bring significant clinical benefits compared with existing therapies. In addition, companies may
be developing biosimilars in other countries that could compete with our products. If competitors are able to obtain marketing
approval for biosimilars referencing our products, our products may become subject to competition from such biosimilars causing the
price for our products and our potential market share to suffer, resulting in lower product sales.
Our completed BLA submission for pediatric SR-aGVHD may not be approved and even if it is approved, we will continue to be
closely regulated by FDA.
As a biological product, our allogeneic cellular medicine, remestemcel-L, for the treatment of pediatrics with SR-aGVHD,
requires regulatory approval from the FDA before it may legally be distributed in U.S. commerce. In particular, remestemcel-L will
require FDA approval of a BLA under Section 351 of the Public Health Service Act to be commercialized.
We have received Fast Track designation from the FDA for remestemcel-L in pediatrics with SR-aGVHD. Fast Track
designation may provide for a more streamlined development or approval process but it does not change the standards for approval
and may be rescinded by the FDA if the product no longer meets the qualifying criteria. A biologic product that receives Fast Track
designation can be eligible for regulatory benefits, including rolling BLA review. Rolling review of a BLA enables individual modules
of the application to be submitted to and reviewed by the FDA on an ongoing basis, rather than waiting for all sections of a BLA to be
completed before submission.
Remestemcel-L had been accepted for Priority Review by the FDA with an action date of September 30, 2020, under the
Prescription Drug User Fee Act (“PDUFA”). In August 2020, the Oncologic Drugs Advisory Committee (“ODAC”) of the FDA voted
in favor that available data from a single-arm Phase 3 trial and evidence from additional studies support the efficacy of remestemcel-L
in pediatric patients with SR-aGVHD. Although the FDA considers the recommendation of the panel, the final decision regarding the
approval of the product is made solely by the FDA, and the recommendations by the panel are non-binding. On September 30, 2020,
the FDA issued a Complete Response Letter to our BLA for remestemcel-L for the treatment of pediatric SR-aGVHD. Despite the
overwhelming ODAC vote, the FDA recommended that we conduct at least one additional randomized, controlled study in adults
and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD.
We have initiated and continue to have discussion with the FDA through a well-established FDA process aimed towards
supporting a resubmission of the current BLA with a six-month review period.
The FDA reviews a BLA to determine, among other things, whether a product is safe, pure and potent and the facility in which
it is manufactured, processed, packed, or held meets standards designed to assure the product’s continued safety, purity and potency.
During the course of review of our BLA, the FDA may request or require additional preclinical, clinical, chemistry and
manufacturing, controls (or CMC), or other data and information. The development and provision of these data and information may
be time consuming and expensive. Our failure to comply, or the failure of our contract manufacturers to satisfy, applicable FDA CMC
requirements could result in a delay or failure to obtain approval of our BLA. If the FDA determines that the application,
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manufacturing process or manufacturing facilities are not acceptable, it will outline the deficiencies in our submission and may request
additional testing or information. The testing and approval process requires substantial time, effort and financial resources, and may
take several years to complete. In addition, the FDA or other regulatory agencies may find the data from our clinical studies
insufficient to support marketing approval. For example, our Phase 3 study for remestemcel-L for the treatment of pediatric SR-
aGVHD, which met the primary clinical endpoint with statistical significance, was conducted as a single-arm study due to the
seriousness of the condition, the rapid clinical deterioration of affected patients, the mounting literature suggesting a meaningful
treatment effect, and the position in the medical community that a randomized controlled trial was neither feasible nor ethical in this
patient population. While we have provided the FDA with comparator outcomes from control subjects, it is possible that the FDA may
not find the data sufficient for approval. In addition, new government requirements, including those resulting from new legislation,
may be established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our products under
development.
It is possible that we will have to participate in other Advisory Committee proceedings for other of our product candidates. FDA
Advisory Committees are convened to conduct public hearings on matters of importance that come before the FDA, to review the
issues involved, and to provide advice and recommendations to the FDA. New product candidates may be referred for review by
Advisory Committees whether the FDA has identified issues or concerns in respect of such candidates or not. Advisory Committee
input and recommendations may be used at the discretion of the FDA. Advisory Committee proceedings are in part conducted
publicly. While the recommendations made by Advisory Committees in respect of marketing applications for any product are not
dispositive, such determinations and recommendations are often influential, and may be made available publicly and to the advantage
of our competitors. In addition, it is possible that safety findings and recommendations as well as other concerns and considerations
raised by Advisory Committee members, who constitute a multi-disciplinary group of experts (including representatives and/or
advocates from the consumer sector), may impact the FDA’s review of our product candidate submissions or labeling
unfavorably. Furthermore, commentary from Advisory Committee proceedings can figure into future product and other litigation.
Even if we receive regulatory approval for our remestemcel-L product, such approval may entail limitations on the indicated
uses for which such product may be marketed and/or require post-marketing testing and surveillance to monitor safety or efficacy of
our product. The FDA may limit further marketing of our product based on the results of post-marketing studies, if compliance with
pre- and post-marketing regulatory standards is not maintained, or if problems occur after our product reaches the marketplace such as
later discovery of previously unknown problems or concerns with our product, including adverse events of unanticipated severity or
frequency, or with our manufacturing processes.
The COVID-19 pandemic could adversely impact the BLA review process for remestemcel-L.
The FDA has accepted for Priority Review our BLA for remestemcel-L for the treatment of pediatric SR-aGVHD. The FDA
reviews a BLA to determine, among other things, whether a product is safe, pure and potent and the facility in which it is
manufactured, processed, packed, or held meets standards designed to assure the product’s continued safety, purity and potency.
Our contract manufacturing partner, Lonza, manufactures remestemcel-L at its facility in Singapore. Singapore is experiencing a
number of COVID-19 cases in its population and has increased the DORSCON level to orange. If new cases continue to be identified,
it could negatively impact business continuity at this facility as staff numbers may be affected by quarantine requirements.
If the business continuity at Lonza’s Singaporean facility is negatively affected, the FDA could be unable to assess the
compliance of such facility with the standards required to assure remestemcel-L’s continued safety, purity and potency. In this case,
the BLA review process for remestemcel-L could be negatively affected.
The ability of FDA inspectors to visit the site to conduct GMP inspections has been impacted by regional travel restrictions, and
other COVID-19 measures. The FDA may in general have slower response times in assessing our BLA filing. Such an impact may
delay the approval of the BLA. FDA has issued guidance for remote inspections – called Remote Interactive Evaluations. It is not
clear that such an evaluation during the pandemic will be offered by FDA or considered adequate for a pre-approval inspection of the
manufacturing site and process.
Risks Related to Collaborators
We rely on third parties to conduct our nonclinical and clinical studies and perform other tasks for us. If these third parties do not
successfully carry out their contractual duties, meet expected deadlines, or comply with regulatory requirements, we may not be
able to obtain regulatory approval for or commercialize our product candidates in a timely and cost-effective manner or at all, and
our business could be substantially harmed.
We have relied upon and plan to continue to rely upon third-party entities, including CROs, academic institutions, hospitals and
other third-party collaborators, to monitor, support, conduct and/or oversee preclinical and clinical studies of our current and future
product candidates. We rely on these parties for execution of our nonclinical and clinical studies, and control only certain aspects of
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their activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable
protocol, legal, regulatory, and scientific standards and our reliance on the CROs does not relieve us of our regulatory responsibilities.
If we or any of these third-parties fail to comply with the applicable protocol, legal, regulatory, and scientific standards, the clinical
data generated in our clinical studies may be deemed unreliable and the FDA, EMA or comparable foreign regulatory authorities may
require us to perform additional clinical studies before approving our marketing applications.
If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative
parties or do so on commercially reasonable terms. In addition, these parties are not our employees, and except for remedies available
to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time and resources to our
on-going nonclinical and clinical programs. If third parties do not successfully carry out their contractual duties or obligations or meet
expected deadlines, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to
adhere to our protocols, regulatory requirements, or for other reasons, our clinical studies may be extended, delayed, or terminated and
we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. Third parties may also
generate higher costs than anticipated. As a result, our results of operations and the commercial prospects for our product candidates
would be harmed, our costs could increase, and our ability to generate revenue could be delayed.
Switching or adding additional third parties involves additional cost and requires management time and focus. In addition, there
is a natural transition period when a new third party commences work. As a result, delays occur, which can materially impact our
ability to meet our desired clinical development timelines. Though we carefully manage our relationships with these third parties,
there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will
not have a material adverse impact on our business, financial condition, and prospects.
Our existing product development and/or commercialization arrangements, and any that we may enter into in the future, may not
be successful, which could adversely affect our ability to develop and commercialize our product candidates.
We are a party to, and continue to seek additional, collaboration arrangements with biopharmaceutical companies for the
development and/or commercialization of our current and future product candidates. We may enter into new arrangements on a
selective basis depending on the merits of retaining certain development and commercialization rights for ourselves as compared to
entering into selective collaboration arrangements with leading pharmaceutical or biotechnology companies for each product
candidate, both in the United States and internationally. To the extent that we decide to enter into collaboration agreements, we will
face significant competition in seeking appropriate collaborators. Any failure to meet our clinical milestones with respect to an
unpartnered product candidate would make finding a collaborator more difficult. Moreover, collaboration arrangements are complex,
costly and time consuming to negotiate, document and implement, and we cannot guarantee that we can successfully maintain such
relationships or that the terms of such arrangements will be favorable to us. If we fail to establish and implement collaboration or other
alternative arrangements, the value of our business and operating results will be adversely affected.
We may not be successful in our efforts to establish, implement and maintain collaborations or other alternative arrangements if
we choose to enter into such arrangements. The terms of any collaboration or other arrangements that we may establish may not be
favorable to us. The management of collaborations may take significant time and resources that distract our management from other
matters.
Our ability to successfully collaborate with any existing or future collaborators may be impaired by multiple factors including:
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a collaborator may shift its priorities and resources away from our programs due to a change in business strategies, or a
merger, acquisition, sale or downsizing of its company or business unit;
a collaborator may cease development in therapeutic areas which are the subject of our strategic alliances;
a collaborator may change the success criteria for a particular program or product candidate thereby delaying or ceasing
development of such program or candidate;
a significant delay in initiation of certain development activities by a collaborator will also delay payments tied to such
activities, thereby impacting our ability to fund our own activities;
a collaborator could develop a product that competes, either directly or indirectly, with our current or future products, if
any;
a collaborator with commercialization obligations may not commit sufficient financial or human resources to the
marketing, distribution or sale of a product;
a collaborator with manufacturing responsibilities may encounter regulatory, resource or quality issues and be unable to
meet demand requirements;
a collaborator may exercise its rights under the agreement to terminate our collaboration;
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a dispute may arise between us and a collaborator concerning the research or development of a product candidate or
commercialization of a product resulting in a delay in milestones, royalty payments or termination of a program and
possibly resulting in costly litigation or arbitration which may divert management attention and resources;
the results of our clinical trials may not match our collaborators’ expectations, even if statistically significant;
a collaborator may not adequately protect or enforce the intellectual property rights associated with a product or product
candidate; and
a collaborator may use our proprietary information or intellectual property in such a way as to invite litigation from a third
party.
Any such activities by our current or future collaborators could adversely affect us financially and could harm our business
reputation.
Risks Related to Our Manufacturing and Supply Chain
We have no experience manufacturing our product candidates at a commercial scale. We may not be able to manufacture our
product candidates in quantities sufficient for development and commercialization if our product candidates are approved, or for
any future commercial demand for our product candidates.
We have manufactured clinical and commercial quantities of our mesenchymal lineage cell product candidates in manufacturing
facilities owned by Lonza Walkersville, Inc. and Lonza Bioscience Singapore Pte. Ltd. (collectively referred to as “Lonza”). We have
commenced manufacture of commercial batches in preparation for a successful BLA review, and subsequent launch. We anticipate a
prior approval inspection of the facilities and our testing laboratories by the FDA. In the event that the inspections result in
observations that need to be corrected, it may delay the approval and launch of this product.
In addition, the production of any biopharmaceutical, particularly cell-based therapies, involves complex processes and
protocols. We cannot provide assurance that such production efforts will enable us to manufacture our product candidates in the
quantities and with the quality needed for clinical trials and/or any resulting commercialization.
If we are unable to do so, our clinical trials and commercialization efforts, if any, may not proceed in a timely fashion and our
business will be adversely affected. If any of our product candidates are approved for commercialization and marketing, we may be
required to manufacture the product in large quantities to meet demand. Producing product in commercial quantities requires
developing and adhering to complex manufacturing processes that are different from the manufacture of a product in smaller
quantities for clinical trials, including adherence to additional and more demanding regulatory standards. Although we believe that we
have developed processes and protocols that will enable us to consistently manufacture commercial-scale quantities of product, we
cannot provide assurance that such processes and protocols will enable us to manufacture our product candidates in quantities that
may be required for commercialization of the product with yields and at costs that will be commercially attractive. If we are unable to
establish or maintain commercial manufacture of the product or are unable to do so at costs that we currently anticipate, our business
will be adversely affected.
We are focusing on the introduction of novel manufacturing approaches with the potential to result in efficiency and yield
improvements to our current process. Certain of these novel approaches include modifying the media used in cell production. Another
approach includes the development of 3-dimensional (“3D”) bioreactor-based production for mesenchymal lineage cells. There is no
guarantee that we will successfully complete either of these processes or meet all applicable regulatory requirements. This may be due
to multiple factors, including the failure to produce sufficient quantities and the inability to produce cells that are equivalent in
physical and therapeutic properties as compared to the products produced using our current manufacturing processes. In the event our
transition to these improved manufacturing processes is unsuccessful, we may not be able to produce certain of our products in a cost-
efficient manner and our business may be adversely affected.
The COVID-19 pandemic may adversely impact the manufacturing and commercialization of remestemcel-L, and other product
candidates.
On October 17, 2019, we announced that we had entered into a manufacturing service agreement with Lonza Bioscience
Singapore Pte. Ltd. for the supply of commercial product for the potential approval and launch of remestemcel-L. We currently also
manufacture our other product candidates with Lonza Singapore.
Due to the COVID-19 pandemic, countries in which Mesoblast has operations, including Singapore - where our contract
manufacturer is located, have implemented some level of quarantine “stay at home” orders, and other restrictions in order to contain
spread of the virus. Continued restrictions on the movement of people and products may adversely affect our and our contract
manufacturer’s ability to operate efficiently. In addition, the COVID-19 pandemic could also adversely affect our or our contract
manufacturer’s ability to acquire raw materials or components required in our manufacturing process, including bone marrow. As a
result, the manufacturing and the commercialization of remestemcel-L and other product candidates could be adversely affected.
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We have also seen substantial delays to lead times for many raw materials, which is being driven by the pandemic. Such
extension of lead times has the potential to delay the ability to manufacture product in a timely manner and could impact our ability to
meet market demand once approved.
We rely on contract manufacturers to supply and manufacture our product candidates. Our business could be harmed if Lonza
fails to provide us with sufficient quantities of these product candidates or fails to do so at acceptable quality levels or prices.
We do not currently have, nor do we plan to acquire, the infrastructure or capability internally to manufacture our mesenchymal
lineage cell product candidates for use in the conduct of our clinical trials, and we currently lack the internal resources and the
capability to manufacture any of our product candidates on a clinical or commercial scale. As a result, we currently depend on Lonza
to manufacture our mesenchymal lineage cell product candidates. Relying on Lonza to manufacture our mesenchymal lineage cell
product candidates entails risks, and Lonza may:
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cease or reduce production or deliveries, raise prices or renegotiate terms;
be unable to meet any product specifications and quality requirements consistently;
delay or be unable to procure or expand sufficient manufacturing capacity, which may harm our reputation or frustrate our
customers;
not have the capacity sufficient to support the scale-up of manufacturing for our product candidates;
have manufacturing and product quality issues related to scale-up of manufacturing;
experience costs and validation of new equipment facilities requirement for scale-up that it will pass on to us;
fail to comply with cGMP and similar international standards;
lose its manufacturing facility in Singapore, stored inventory or laboratory facilities through fire or other causes, or other
loss of materials necessary to manufacture our product candidates;
experience disruptions to its operations by conditions unrelated to our business or operations, including the bankruptcy or
interruptions of its suppliers;
experience carrier disruptions or increased costs that it will pass on to us;
fail to secure adequate supplies of essential ingredients in our manufacturing process;
experience failure of third parties involved in the transportation, storage or distribution of our products, including the
failure to deliver supplies it uses for the manufacture of our product candidates under specified storage conditions and in a
timely manner;
terminate agreements with us; and
appropriate or misuse our trade secrets and other proprietary information.
Any of these events could lead to delays in the development of our product candidates, including delays in our clinical trials, or
failure to obtain regulatory approval for our product candidates, or it could impact our ability to successfully commercialize our
current product candidates or any future products. Some of these events could be the basis for FDA or other regulatory action,
including injunction, recall, seizure or total or partial suspension of production.
In addition, the lead time needed to establish a relationship with a new manufacturer can be lengthy and expensive, and we may
experience delays in meeting demand in the event we must switch to a new manufacturer. We are expanding our manufacturing
collaborations in order to meet future demand and to provide back-up manufacturing options, which also involves risk and requires
significant time and resources. Our future collaborators may need to expand their facilities or alter the facilities to meet future demand
and changes in regulations. These activities may lead to delays, interruptions to supply, or may prove to be more costly than
anticipated. Any problems in our manufacturing process could have a material adverse effect on our business, results of operations and
financial condition.
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We may not be able to manufacture or commercialize our product candidates in a profitable manner.
We intend to implement a business model under which we control the manufacture and supply of our product candidates,
including but not exclusively, through our product suppliers, including Lonza. We and the suppliers of our product candidates,
including Lonza, have no experience manufacturing our product candidates at commercial scale. Accordingly, there can be no
assurance as to whether we and our suppliers will be able to scale-up the manufacturing processes and implement technological
improvements in a manner that will allow the manufacture of our product candidates in a cost effective manner. Our or our
collaborators’ inability to sell our product candidates at a price that exceeds our cost of manufacture by an amount that is profitable for
us will have a material adverse result on the results of our operations and our financial condition.
Collaborators’ ability to identify, test and verify new donor tissue in order to create new master cell banks involves many risks.
The initial stage of manufacturing involves obtaining mesenchymal lineage cell-containing bone marrow from donors, for which
we currently rely on our suppliers. Mesenchymal lineage cells are isolated from each donor’s bone marrow and expanded to create a
master cell bank. Each individual master cell bank comes from a single donor. A single master cell bank can source many production
runs, which in turn can produce up to thousands of doses of a given product, depending on the dose level. The process of identifying
new donor tissue, testing and verifying its validity in order to create new master cell banks and validating such cell bank with the FDA
and other regulatory agencies is time consuming, costly and prone to the many risks involved with creating living cell products. There
could be consistency or quality control issues with any new master cell bank. Although we believe we and our collaborators have the
necessary know-how and processes to enable us to create master cell banks with consistent quality and within the timeframe necessary
to meet projected demand and we have begun doing so, we cannot be certain that we or our collaborators will be able to successfully
do so, and any failure or delays in creating new master cell banks may have a material adverse impact on our business, results of
operations, financial conditions and growth prospects and could result in our inability to continue operations.
We and our collaborators depend on a limited number of suppliers for our product candidates’ materials, equipment or supplies
and components required to manufacture our product candidates. The loss of these suppliers, or their failure to provide quality
supplies on a timely basis, could cause delays in our current and future capacity and adversely affect our business.
We and our collaborators depend on a limited number of suppliers for the materials, equipment and components required to
manufacture our product candidates, as well as various “devices” or “carriers” for some of our programs (e.g., the catheter for use with
MPC-150-IM, and the hyaluronic acid used for disc repair). The main consumable used in our manufacturing process is our media,
which currently is sourced from fetal bovine serum (“FBS”). This material comes from limited sources, and as a result is expensive.
Consequently, we or our collaborators may not be able to obtain sufficient quantities of our product candidates or other critical
materials equipment and components in the future, at affordable prices or at all. A delay or interruption by our suppliers may also
harm our business, and operating results. In addition, the lead time needed to establish a relationship with a new supplier can be
lengthy, and we or our collaborators may experience delays in meeting demand in the event we must switch to a new supplier. The
time and effort to qualify for and, in some cases, obtain regulatory approval for a new supplier could result in additional costs,
diversion of resources or reduced manufacturing yields, any of which would negatively impact our operating results. Our and our
collaborators’ dependence on single-source suppliers exposes us to numerous risks, including the following:
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our or our collaborators’ suppliers may cease or reduce production or deliveries, raise prices or renegotiate terms;
our or our collaborators’ suppliers may not be able to source materials, equipment or supplies and components required to
manufacture our product candidates as a result of the COVID-19 outbreak;
we or our collaborators may be unable to locate suitable replacement suppliers on acceptable terms or on a timely basis, or
at all; and
delays caused by supply issues may harm our reputation, frustrate our customers and cause them to turn to our competitors
for future needs.
We and our collaborators and Lonza are subject to significant regulation with respect to manufacturing our product candidates.
The Lonza manufacturing facilities on which we rely may not continue to meet regulatory requirements or may not be able to meet
supply demands.
All entities involved in the preparation of therapeutics for clinical studies or commercial sale, including our existing
manufacturers, including Lonza, are subject to extensive regulation. Components of a finished therapeutic product approved for
commercial sale or used in late-stage clinical studies must be manufactured in accordance with current international Good
Manufacturing Practice and other international regulatory requirements. These regulations govern manufacturing processes and
procedures (including record keeping) and the implementation and operation of quality systems to control and assure the quality of
investigational products and products approved for sale. Poor control of production processes can lead to the introduction of
contaminants or to inadvertent changes in the properties or stability of our product candidates. We, our collaborators, or suppliers must
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supply all necessary documentation in support of a BLA on a timely basis and must adhere to current Good Laboratory Practice and
current Good Manufacturing Practice regulations enforced by the FDA and other regulatory agencies through their facilities inspection
program. Lonza and other suppliers have never produced a commercially approved cellular therapeutic product and therefore have not
yet obtained the requisite regulatory authority approvals to do so.
Before we can begin commercial manufacture of our products for sale in the United States, we must obtain FDA regulatory
approval for the product, in addition to the approval of the processes and quality systems associated with the manufacturing of such
product, which requires a successful FDA inspection of the facility handling the manufacturing of our product, including Lonza’s
manufacturing facilities. The novel nature of our product candidates creates significant challenges in regards to manufacturing. For
example, the U.S. federal and state governments and other jurisdictions impose restrictions on the acquisition and use of tissue,
including those incorporated in federal Good Tissue Practice regulations. We may not be able to identify or develop sources for the
cells necessary for our product candidates that comply with these laws and regulations.
In addition, the regulatory authorities may, at any time before or after product approval, audit or inspect a manufacturing facility
involved with the preparation of our product candidates or raw materials or the associated quality systems for compliance with the
regulations applicable to the activities being conducted. Although we oversee each contract manufacturer involved in the production
of our product candidates, we cannot control the manufacturing process of, and are dependent on, the contract manufacturer for
compliance with the regulatory requirements. If the contract manufacturer is unable to comply with manufacturing regulations, we
may be subject to fines, unanticipated compliance expenses, recall or seizure of any approved products, total or partial suspension of
production and/or enforcement actions, including injunctions, and criminal or civil prosecution. These possible sanctions would
adversely affect our business, results of operations and financial condition. If the manufacturer fails to maintain regulatory
compliance, the FDA or other applicable regulatory authority can impose regulatory sanctions including, among other things, refusal
to approve a pending application for a new drug product or biologic product, withdrawal of an approval, or suspension of production.
As a result, our business, financial condition, and results of operations may be materially harmed.
We will rely on third parties to perform many necessary services for the commercialization of our product candidates, including
services related to the distribution, storage and transportation of our products.
We will rely upon third parties for certain storage, distribution and other logistical services. In accordance with certain laws,
regulations and specifications, our product candidates must be stored and transported at extremely low temperatures within a certain
range. If these environmental conditions deviate, our product candidates’ remaining shelf-lives could be impaired or their efficacy and
safety could become adversely affected, making them no longer suitable for use. If any of the third parties that we intend to rely upon
in our storage, distribution and other logistical services process fail to comply with applicable laws and regulations, fail to meet
expected deadlines, or otherwise do not carry out their contractual duties to us, or encounter physical damage or natural disaster at
their facilities, our ability to deliver product to meet commercial demand may be significantly impaired. In addition, as our cellular
therapies will constitute a new form of product, experience in commercial distribution of such therapies in the United States is
extremely limited, and as such is subject to execution risk. While we intend to work closely with our selected distribution logistics
providers to define appropriate parameters for their activities to ensure product remains intact throughout the process, there is no
assurance that such logistics providers will be able to maintain all requirements and handle and distribute our products in a manner
that does not significantly impair them, which may impact our ability to satisfy commercial demand.
Product recalls or inventory losses caused by unforeseen events may adversely affect our operating results and financial condition.
Our product candidates are manufactured, stored and distributed using technically complex processes requiring specialized
facilities, highly specific raw materials and other production constraints. The complexity of these processes, as well as strict company
and government standards for the manufacture, storage and distribution of our product candidates, subjects us to risks. For example,
during the manufacturing process we have from time to time experienced several different types of issues that have led to a rejection
of various batches. Historically, the most common reasons for batch rejections include major process deviations during the production
of a specific batch and failure of manufactured product to meet one or more specifications. While product candidate batches released
for the use in clinical trials or for commercialization undergo sample testing, some latent defects may only be identified following
product release. In addition, process deviations or unanticipated effects of approved process changes may result in these product
candidates not complying with stability requirements or specifications. The occurrence or suspected occurrence of production and
distribution difficulties can lead to lost inventories, and in some cases product recalls, with consequential reputational damage and the
risk of product liability. The investigation and remediation of any identified problems can cause production delays, substantial
expense, lost sales and delays of new product launches. In the event our production efforts require a recall or result in an inventory
loss, our operating results and financial condition may be adversely affected.
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Risks Related to Commercialization of Our Product Candidates
Our future commercial success depends upon attaining significant market acceptance of our product candidates, if approved,
among physicians, patients and healthcare payors.
Even when product development is successful and regulatory approval has been obtained, our ability to generate significant
revenue depends on the acceptance of our products by physicians, payors and patients. Many potential market participants have
limited knowledge of, or experience with, cell therapy-based products, so gaining market acceptance and overcoming any safety or
efficacy concerns may be more challenging than for more traditional therapies. Our efforts to educate the medical community and
third-party payors on the benefits of our product candidates may require significant resources and may never be successful. Such
efforts to educate the marketplace may require more or different resources than are required by the conventional therapies marketed by
our competitors. We cannot assure you that our products will achieve the expected market acceptance and revenue if and when they
obtain the requisite regulatory approvals. Alternatively, even if we obtain regulatory approval, that approval may be for indications or
patient populations that are not as broad as intended or desired or may require labeling that includes significant use or distribution
restrictions or safety warnings. The market acceptance of each of our product candidates will depend on a number of factors,
including:
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the efficacy and safety of the product candidate, as demonstrated in clinical trials;
the clinical indications for which the product is approved, and the label approved by regulatory authorities for use with the
product, including any warnings or contraindications that may be required on the label;
acceptance by physicians, patients, and with pediatric indications by parents/caregivers of the product as a safe and
effective treatment;
the cost, safety and efficacy of treatment in relation to alternative treatments;
the continued projected growth of markets for our various indications;
relative convenience and ease of administration;
the prevalence and severity of adverse side effects;
the effectiveness of our, and our collaborators’ sales and marketing efforts; and
sufficient third-party insurance and other payor (e.g., governmental) coverage and reimbursement.
Market acceptance is critical to our ability to generate significant revenue. Any product candidate, if approved and
commercialized, may be accepted in only limited capacities or not at all. If any approved products are not accepted by the market to
the extent that we expect, we may not be able to generate significant revenue and our business would suffer.
If, in the future, we are unable to establish our own commercial capabilities across sales, marketing and distribution, or enter into
licensing or collaboration agreements for these purposes, we may not be successful in independently commercializing any future
products.
We have limited sales, marketing or distribution infrastructure and experience. Commercializing our product candidates, if such
product candidates obtain regulatory approval, would require significant sales, distribution and marketing capabilities. Where and
when appropriate, we may elect to utilize contract sales forces or distribution collaborators to assist in the commercialization of our
product candidates. If we enter into arrangements with third parties to perform sales, marketing and distribution/price reporting
services for our product candidates, the resulting revenue or the profitability from this revenue to us may be lower than if we had sold,
marketed and distributed that product ourselves. In addition, we may not be successful in entering into arrangements with third parties
to sell, market and distribute any future products or may be unable to do so on terms that are favorable to us. We may have little
control over such third parties, and any of these third parties may fail to devote the necessary resources and attention to sell, market
and distribute our current or any future products effectively.
To the extent we are unable to engage third parties to assist us with these functions, we will have to invest significant amounts
of financial and management resources, some of which will need to be committed prior to any confirmation that any of our proprietary
product candidates will be approved. For any future products for which we decide to perform sales, marketing and distribution
functions ourselves, we could face a number of additional risks, including:
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our inability to recruit and retain adequate numbers of effective sales and marketing personnel or to develop alternative
sales channels;
the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any
future products;
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the inability of account teams to obtain formulary acceptance for our products, allowing for reimbursement and hence
patient access;
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage
relative to companies with multiple products; and
unforeseen costs and expenses associated with creating and maintaining an independent sales and marketing organization.
We face substantial competition, which may result in others discovering, developing or commercializing products before, or more
successfully, than we do.
The biopharmaceutical industry is highly competitive and subject to rapid change. The industry continues to expand and evolve
as an increasing number of competitors and potential competitors enter the market. Many of our potential competitors have
significantly greater development, financial, manufacturing, marketing, technical and human resources than we do. Large
pharmaceutical companies, in particular, have extensive experience in conducting clinical trials, obtaining regulatory approvals,
manufacturing pharmaceutical and biologic products and commercializing such therapies. Recent and potential future merger and
acquisition activity in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a
smaller number of our competitors. Established pharmaceutical companies may also invest heavily to accelerate discovery and
development of novel compounds that could make our product candidates obsolete. As a result of all of these factors, our competitors
may succeed in obtaining patent protection and/or FDA approval or discovering, developing and commercializing our product
candidates or competitors to our product candidates before we do. Specialized, smaller or early-stage companies may also prove to be
significant competitors, particularly those with a focus and expertise in cell therapies. In addition, any new product that competes with
an approved product must demonstrate compelling advantages in efficacy, convenience, tolerability and safety in order to overcome
price competition and to be commercially successful. If we are not able to compete effectively against potential competitors, our
business will not grow and our financial condition and results of operations will suffer.
Our marketed products may be used by physicians for indications that are not approved by the FDA. If the FDA finds that we
marketed our products in a manner that promoted off-label use, we may be subject to civil or criminal penalties.
Under the Federal Food, Drug and Cosmetic Act (“FDCA”), and other laws, if any of our product candidates are approved by
the FDA, we would be prohibited from promoting our products for off-label uses. This means, for example, that we would not be able
to make claims about the use of our marketed products outside of their approved indications, and we would not be able to proactively
discuss or provide information on off-label uses of such products, with very specific and limited exceptions. The FDA does not,
however, prohibit physicians from prescribing products for off-label uses in the practice of medicine. Should the FDA determine that
our activities constituted the promotion of off-label use, the FDA could issue a warning or untitled letter or, through the Department of
Justice, bring an action for seizure or injunction, and could seek to impose fines and penalties on us and our executives. In addition,
failure to follow FDA rules and guidelines relating to promotion and advertising can result in, among other things, the FDA’s refusal
to approve a product, the suspension or withdrawal of an approved product from the market, product recalls, fines, disgorgement of
money, operating restrictions, injunctions or criminal prosecutions, and also may figure into civil litigation against us.
Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs. For
example, in 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act,
or collectively, the Affordable Care Act, was passed. The Affordable Care Act is a sweeping law intended to broaden access to health
insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency
requirements for healthcare and the health insurance industry, impose new taxes and fees on the healthcare industry and impose
additional health policy reforms. There have been a number of judicial and congressional challenges to certain aspects of the
Affordable Care Act. We can provide no assurance that the Affordable Care Act, as currently enacted or as amended in the future, will
not adversely affect our business and financial results, and we cannot predict how future federal or state legislative or administrative
changes relating to healthcare reform will affect our business.
Currently, the outcome of potential reforms and changes to government negotiation/regulation to healthcare costs are unknown.
If changes in policy limit reimbursements that we are able to receive through federal programs, it could negatively impact
reimbursement levels from those payors and private payors, and our business, revenues or profitability could be adversely affected.
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If we or our collaborators fail to obtain and sustain an adequate level of reimbursement for our products by third-party payors,
sales and profitability would be adversely affected.
Our and our collaborators’ ability to commercialize any products successfully will depend, in part, on the extent to which
coverage and reimbursement for our products and related treatments will be available from government healthcare programs, private
health insurers, managed care plans, and other organizations. Additionally, even if there is a commercially viable market, if the level
of third-party reimbursement is below our expectations, our revenue and profitability could be materially and adversely affected.
Third-party payors, such as government programs, including Medicare or Medicaid in the United States, or private healthcare
insurers, carefully review and increasingly question the coverage of, and challenge the prices charged for medical products and
services, and many third-party payors limit or delay coverage of or reimbursement for newly approved healthcare products.
Reimbursement rates from private health insurance companies vary depending on the company, the insurance plan and other factors,
including the third-party payor’s determination that use of a product is:
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a covered benefit under its health plan;
safe, effective and medically necessary;
appropriate for the specific patient;
cost-effective; and
neither experimental nor investigational.
A current trend in the U.S. healthcare industry as well as in other countries around the world is toward cost containment. Large
public and private payors, managed care organizations, group purchasing organizations and similar organizations are exerting
increasing influence on decisions regarding the use of, and reimbursement levels for, particular treatments. In particular, third-party
payors may limit the covered indications. Cost-control initiatives could decrease the price we might establish for any product, which
could result in product revenue and profitability being lower than anticipated.
There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more
limited than the purposes for which the drug is approved by the FDA or other regulatory authorities. Moreover, eligibility for coverage
and reimbursement does not imply that a drug will be paid for in all cases or at a rate that covers our costs, including research,
development, manufacture, sale and distribution expenses. Interim reimbursement levels for new drugs, if applicable, may also be
insufficient to cover our and any collaborator’s costs and may not be made permanent. Reimbursement rates may vary according to
the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs
and may be incorporated into existing payments and treatment codes for other services. Our inability to promptly obtain coverage and
profitable payment rates from both government-funded and private payors for any approved products that we develop could have a
material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial
condition.
Furthermore, reimbursement systems in international markets vary significantly by country and by region, and reimbursement
approvals must be obtained on a country-by-country basis. Our existing or future collaborators, if any, may elect to reduce the price of
our products in order to increase the likelihood of obtaining reimbursement approvals which could adversely affect our revenues and
profits. In many countries, including for example in Japan, products cannot be commercially launched until reimbursement is
approved. Further, the post-approval price negotiation process in some countries can exceed 12 months. In addition, pricing and
reimbursement decisions in certain countries can be affected by decisions taken in other countries, which can lead to mandatory price
reductions and/or additional reimbursement restrictions across a number of other countries, which may thereby adversely affect our
sales and profitability. In the event that countries impose prices which are not sufficient to allow us or our collaborators to generate a
profit, our collaborators may refuse to launch the product in such countries or withdraw the product from the market, which would
adversely affect sales and profitability.
Due to the novel nature of our cell therapy and the potential for our product candidates to offer therapeutic benefit in a single
administration, we face uncertainty related to pricing and reimbursement for these product candidates.
Our target patient populations for some of our product candidates may be relatively small, and as a result, the pricing and
reimbursement of our product candidates, if approved, must be adequate to support commercial infrastructure. If we are unable to
obtain adequate levels of reimbursement, our ability to successfully market and sell our product candidates will be adversely affected.
Due to the novel nature of our cell therapy technology, the manner and level at which reimbursement is provided for services related
to our product candidates (e.g., for administration of our product to patients) is uncertain. Inadequate reimbursement for such services
may lead to physician resistance and adversely affect our ability to market or sell our products. Further, if the results of our clinical
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trials and related cost benefit analyses do not clearly demonstrate the efficacy or overall value of our product candidates in a manner
that is meaningful to prescribers and payors, our pricing and reimbursement may be adversely affected.
Price controls may be imposed in foreign markets, which may adversely affect our future profitability.
In some countries, particularly EU member states, Japan, Australia and Canada, the pricing of prescription drugs is subject to
governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after receipt of
marketing approval for a product. In addition, there can be considerable pressure by governments and other stakeholders on prices and
reimbursement levels, including as part of cost containment measures. Political, economic and regulatory developments may further
complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used
by various EU member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further
reduce prices. In some countries, we or our collaborators may be required to conduct a clinical trial or other studies that compare the
cost-effectiveness of our product candidates to other available therapies in order to obtain or maintain reimbursement or pricing
approval. Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement
levels within the country of publication and other countries. If reimbursement of our products is unavailable or limited in scope or
amount, or if pricing is set at unsatisfactory levels, our business, revenues or profitability could be adversely affected.
If the market opportunities for our product candidates are smaller than we believe they are, our revenues may be adversely affected
and our business may suffer. Because the target patient populations of certain of our product candidates are small, we must be
able to successfully identify physicians with access to appropriate patients and achieve a significant market share to maintain
profitability and growth.
Our projections of the number of people with diseases targeted by our product candidates are based on estimates. These
estimates may prove to be incorrect and new studies may change the estimated incidence or prevalence of these diseases. In addition,
physicians who we believe have access to patients in need of our products may in fact not often treat the diseases targeted by our
product candidates, and may not be amenable to use of our product. Further, the number of patients in the United States, Europe and
elsewhere may turn out to be lower than expected, may not be otherwise amenable to treatment with our products, or new patients may
become increasingly difficult to identify or gain access to, all of which would adversely affect our results of operations and our
business.
We are exposed to risks related to our licensees and our international operations, and failure to manage these risks may adversely
affect our operating results and financial condition.
We and our subsidiaries operate out of Australia, the United States, Singapore, the United Kingdom and Switzerland. We have
licensees, with rights to commercialize products based on our MSC technology, including JCR in Japan. Our primary manufacturing
collaborator, Lonza, serves us primarily out of their facilities in Singapore, and through contractual relationships with third parties, has
access to storage facilities in the U.S., Europe, Australia and Singapore. As a result, a significant portion of our operations are
conducted by and/or rely on entities outside the markets in which certain of our trials take place, our suppliers are sourced, our product
candidates are developed, and, if any such product candidates obtain regulatory approval, our products may be sold. Accordingly, we
import a substantial number of products and/or materials into such markets. We may be denied access to our customers, suppliers or
other collaborators or denied the ability to ship products from any of these sites as a result of a closing of the borders of the countries
in which we operate, or in which these operations are located, due to economic, legislative, political, health or military conditions in
such countries. If any of our product candidates are approved for commercialization, we may enter into agreements with third parties
to market them on a worldwide basis or in more limited geographical regions. We expect that we will be subject to additional risks
related to entering into international business relationships, including:
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unexpected changes in tariffs, trade barriers and regulatory requirements;
economic weakness, including inflation, or political instability in particular foreign economies and markets;
logistics and regulations associated with shipping cell samples and other perishable items, including infrastructure
conditions and transportation delays;
potential import and export issues and other trade barriers and restrictions with the U.S. Customs and Border Protection
and similar bodies in other jurisdictions;
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
workforce uncertainty in countries where labor unrest is more common than in the United States;
reduced protection for intellectual property rights in some countries and practical difficulties of enforcing intellectual
property and contract rights abroad;
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changes in diplomatic and trade relationships, including new tariffs, trade protection measures, import or export licensing
requirements, trade embargoes and other trade barriers;
tariffs imposed by the U.S. on goods from other countries, including the recently implemented tariffs and additional tariff
that have been proposed by the U.S. government on various imports from China and the EU and by the governments of
these jurisdictions on certain U.S. goods, and any other possible tariffs that may be imposed on products such as ours, the
scope and duration of which, if implemented, remains uncertain;
deterioration of political relations between the U.K. and the EU, which could have a material adverse effect on our sales
and operations in these countries;
changes in social, political and economic conditions or in laws, regulations and policies governing foreign trade,
manufacturing, development and investment both domestically as well as in the other countries and jurisdictions into
which we sell our products;
fluctuations in currency exchange rates and the related effect on our results of operations;
increased financial accounting and reporting burdens and complexities;
potential increases on tariffs or restrictions on trade generally;
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including
earthquakes, typhoons, floods and fires.
Use of animal-derived materials could harm our product development and commercialization efforts.
Some of the manufacturing materials and/or components that we use in, and which are critical to, implementation of our
technology involve the use of animal-derived products, including FBS. Suppliers or regulatory changes may limit or restrict the
availability of such materials for clinical and commercial use. While FBS is commonly used in the production of various marketed
biopharmaceuticals, the suppliers of FBS that meet our strict quality standards are limited in number and region. As such, to the extent
that any such suppliers or regions face an interruption in supply (for example, if there is a new occurrence of so-called “mad cow
disease”), it may lead to a restricted supply of the serum currently required for our product manufacturing processes. Any restrictions
on these materials would impose a potential competitive disadvantage for our products or prevent our ability to manufacture our cell
products. The FDA has issued regulations for controls over bovine material in animal feed. These regulations do not appear to affect
our ability to purchase the manufacturing materials we currently use. However, the FDA may propose new regulations that could
affect our operations. Our inability to develop or obtain alternative compounds would harm our product development and
commercialization efforts. There are certain limitations in the supply of certain animal-derived materials, which may lead to delays in
our ability to complete clinical trials or eventually to meet the anticipated market demand for our cell products.
If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit
commercialization of our product candidates.
We face an inherent risk of product liability as a result of the human clinical use of our product candidates and will face an even
greater risk if we commercialize any products. For example, we may be sued if any product we develop allegedly causes injury or is
found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such product liability claims may
include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence,
strict liability, and a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot
successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit
commercialization of our product candidates. Even a successful defense would require significant financial and management
resources. Regardless of the merits or eventual outcome, liability claims may result in:
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decreased demand for our products, even if such products are approved;
injury to our reputation;
withdrawal of clinical trial participants;
costs to defend the related litigations;
a diversion of management’s time and our resources;
substantial monetary awards to trial participants or patients;
product recalls, withdrawals, or labeling, marketing or promotional restrictions;
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increased cost of liability insurance;
loss of revenue;
the inability to commercialize our product candidates; and
a decline in our ordinary share price.
Failure to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product
liability claims could prevent or inhibit the commercialization of products we develop. Additionally, our insurance policies have
various exclusions, and we may be subject to a product liability claim for which we have no coverage or reduced coverage. Any claim
that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by
our insurance or that is in excess of the limits of our insurance coverage. We will have to pay any amounts awarded by a court or
negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be
able to obtain, sufficient capital to pay such amounts.
Risks Related to Our Intellectual Property
We may not be able to protect our proprietary technology in the marketplace.
Our success will depend, in part, on our ability to obtain patents, protect our trade secrets and operate without infringing on the
proprietary rights of others. We rely upon a combination of patents, trade secret protection, and confidentiality agreements to protect
the intellectual property of our product candidates. Patents might not be issued or granted with respect to our patent applications that
are currently pending, and issued or granted patents might later be found to be invalid or unenforceable, be interpreted in a manner
that does not adequately protect our current product or any future products, or fail to otherwise provide us with any competitive
advantage. As such, we do not know the degree of future protection that we will have on our proprietary products and technology, if
any, and a failure to obtain adequate intellectual property protection with respect to our product candidates and proprietary technology
could have a material adverse impact on our business.
Filing, prosecuting and defending patents throughout the world would be prohibitively expensive, so our policy is to patent
technology in jurisdictions with significant or otherwise relevant commercial opportunities or activities. However, patent protection
may not be available for some of the products or technology we are developing. If we must spend significant time and money
protecting or enforcing our patents, designing around patents held by others or licensing, potentially for large fees, patents or other
proprietary rights held by others, our business, results of operations and financial condition may be harmed.
The patent positions of biopharmaceutical products are complex and uncertain.
The scope and extent of patent protection for our product candidates are particularly uncertain. To date, our principal product
candidates have been based on specific subpopulations of known and naturally occurring adult stem cells. We anticipate that the
products we develop in the future will continue to include or be based on the same or other naturally occurring stem cells or
derivatives or products thereof. Although we have sought and expect to continue to seek patent protection for our product candidates,
their methods of use and methods of manufacture, any or all of them may not be subject to effective patent protection. Publication of
information related to our product candidates by us or others may prevent us from obtaining or enforcing patents relating to these
products and product candidates. Furthermore, others may independently develop similar products, may duplicate our products, or
may design around our patent rights. In addition, any of our issued patents may be declared invalid. If we fail to adequately protect our
intellectual property, we may face competition from companies who attempt to create a generic product to compete with our product
candidates. We may also face competition from companies who develop a substantially similar product to our other product
candidates that may not be covered by any of our patents.
Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively
expensive, and our intellectual property rights in some countries outside the U.S. can be less extensive than those in the U.S. In
addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in
the U.S. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S., or
from selling or importing products made using our inventions in and into the U.S. or other jurisdictions. Competitors may use our
technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export
otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the U.S. These
products may compete with our current or future products, if any, and our patents or other intellectual property rights may not be
effective or sufficient to prevent them from competing.
Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign
jurisdictions. The legal systems of certain countries do not favor the enforcement of patents, trade secrets and other intellectual
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property protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement
of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent
rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business,
could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could
provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies
awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the
world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
We may be unable to adequately prevent disclosure of trade secrets and other proprietary information.
We maintain certain of our proprietary know-how and technological advances as trade secrets, especially where we do not
believe patent protection is appropriate or obtainable, including, but not exclusively, with respect to certain aspects of the
manufacturing of our products. However, trade secrets are difficult to protect. We take a number of measures to protect our trade
secrets including, limiting disclosure, physical security and confidentiality and non-disclosure agreements. We enter into
confidentiality agreements with our employees, consultants, outside scientific collaborators, contract manufacturing partners,
sponsored researchers and other advisors and third parties to protect our trade secrets and other proprietary information. These
agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of
unauthorized disclosure of confidential information. In addition, others may independently discover our trade secrets and proprietary
information. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights.
Failure to obtain or maintain trade secret protection, or failure to adequately protect our intellectual property could enable competitors
to develop generic products or use our proprietary information to develop other products that compete with our products or cause
additional, material adverse effects upon our business, results of operations and financial condition.
We may be forced to litigate to enforce or defend our intellectual property rights, and/or the intellectual property rights of our
licensors.
We may be forced to litigate to enforce or defend our intellectual property rights against infringement by competitors, and to
protect our trade secrets against unauthorized use. In so doing, we may place our intellectual property at risk of being invalidated,
unenforceable, or limited or narrowed in scope and may no longer be used to prevent the manufacture and sale of competitive product.
Further, an adverse result in any litigation or other proceedings before government agencies such as the United States Patent and
Trademark Office (“USPTO”), may place pending applications at risk of non-issuance. Further, interference proceedings, derivation
proceedings, entitlement proceedings, ex parte reexamination, inter partes reexamination, inter partes review, post-grant review, and
opposition proceedings provoked by third parties or brought by the USPTO or any foreign patent authority may be used to challenge
inventorship, ownership, claim scope, or validity of our patent applications. Furthermore, because of the substantial amount of
discovery required in connection with intellectual property litigation, there is a risk that some of our confidential and proprietary
information could be compromised by disclosure during this type of litigation.
Intellectual property disputes could cause us to spend substantial resources and distract our personnel from their normal
responsibilities.
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur
significant expenses, and could distract our technical and/or management personnel from their normal responsibilities. In addition,
there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities
analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the market price of our ADSs
and ordinary shares. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available
for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other
resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of litigation
proceedings more effectively than we can because of their greater financial resources and personnel. In addition, the uncertainties
associated with litigation could have a material adverse effect on our ability to raise the funds necessary to conduct our clinical trials,
continue our internal research programs, in-license needed technology or enter into strategic collaborations that would help us bring
our product candidates to market. As a result, uncertainties resulting from the initiation and continuation of patent litigation or other
proceedings could have a material adverse effect on our ability to compete in the marketplace.
U.S. patent reform legislation and court decisions could increase the uncertainties and costs surrounding the prosecution of our
patent applications and the enforcement or defense of our issued U.S. patents.
Changes in either the patent laws or interpretation of the patent laws in the United States could increase the uncertainties and
costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. Under the current patent
laws, a third party that files a patent application in the USPTO before us for a particular invention could therefore be awarded a patent
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covering such invention even if we had made that invention before it was made by such third party. This requires us to be cognizant of
the time from invention to filing of a patent application.
The current US legislation allows third party submissions of prior art to the USPTO during patent prosecution and additional
procedures for attacking the validity of a patent through USPTO administered post-grant proceedings, including post-grant
review, inter partes review, and derivation proceedings. Because a lower evidentiary standard applies in USPTO proceedings
compared to the evidentiary standards applied in United States federal courts in actions seeking to invalidate a patent claim, a third
party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the
same evidence would be insufficient to invalidate the claim if challenged in a district court action. Accordingly, a third party may
attempt to use available USPTO procedures to invalidate our patent claims that would not otherwise have been invalidated if first
challenged by the third party in a district court action. These post-grant review (PGR) proceedings, which are similar to European
“opposition” proceedings and provide third-party petitioners with the ability to challenge the validity of a patent on more expansive
grounds than those permitted in other USTPO proceedings, allow for validity to be examined by the USPTO based not only on prior
art patents and publications, but also on prior invalidating public use and sales, the presence of non-statutory subject matter in the
patent claims and inadequate written description or lack of enablement. Discovery for PGR proceedings is accordingly likely to be
expansive given that the issues addressed in PGR are more comprehensive than those addressed in other USPTO proceedings.
As compared to intellectual property-reliant companies generally, the patent positions of companies in the development and
commercialization of biologics and pharmaceuticals are particularly uncertain. Recent U.S. Supreme Court rulings have narrowed the
scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. These
rulings have created uncertainty with respect to the validity and enforceability of patents, even once obtained. Depending on future
actions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in
unpredictable ways that could have a material adverse effect on our existing patent portfolio and our ability to protect and enforce our
intellectual property in the future.
If third parties claim that intellectual property used by us infringes upon their intellectual property, commercialization of our
product candidates and our operating profits could be adversely affected.
There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual
property rights in the biopharmaceutical industry. We may, from time to time, be notified of claims that we are infringing upon
patents, trademarks, copyrights, or other intellectual property rights owned by third parties, and we cannot provide assurances that
other companies will not, in the future, pursue such infringement claims against us or any third-party proprietary technologies we have
licensed. Any such claims could also be expensive and time consuming to defend and divert management’s attention and resources,
and could delay or prevent us from commercializing our product candidates. Our competitive position could suffer as a result.
Although we have reviewed certain third-party patents and patent filings that we believe may be relevant to our product candidates,
we have not conducted a freedom-to-operate search or analysis for our product candidates, and we may not be aware of patents or
pending or future patent applications that, if issued, would block us from commercializing our product candidates. Thus, we cannot
guarantee that our product candidates, or our commercialization thereof, do not and will not infringe any third party’s intellectual
property.
If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under
similar legislation, thereby potentially extending the term of our marketing exclusivity of our product candidates, our business may
be materially harmed.
Depending on the timing, duration and specifics of FDA marketing approval of our product candidates, if any, one of the U.S.
patents covering each of such approved product(s) or the use thereof may be eligible for up to five years of patent term restoration
under the Hatch-Waxman Act. The Hatch-Waxman Act allows a maximum of one patent to be extended per FDA approved product.
Patent term extension also may be available in certain foreign countries upon regulatory approval of our product candidates, including
by the EMA in the EU or the PMDA in Japan. Nevertheless, we may not be granted patent term extension either in the United States
or in any foreign country because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of
relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the term of extension, as well as the scope of patent
protection during any such extension, afforded by the governmental authority could be less than we request. In addition, if a patent we
wish to extend is owned by another party and licensed to us, we may need to obtain approval and cooperation from our licensor to
request the extension.
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If we are unable to obtain patent term extension or restoration, or the term of any such extension is less than we request, the
period before we might face generic or follow-on competition could be shortened and we may not be able to stop our competitors from
launching competing products following our patent expiration, and our revenue could be reduced, possibly materially.
Risks Related to Our Business and Industry
If we fail to attract and keep senior management and key scientific, commercial, regulatory affairs and other personnel, we may be
unable to successfully develop our product candidates, conduct our clinical trials and commercialize our product candidates.
We are highly dependent on members of our executive management, particularly Dr. Silviu Itescu, our Chief Executive Officer.
Dr. Itescu was an early pioneer in the study and clinical development of cell therapeutics and is globally recognized in the field of
regenerative medicine. The loss of the services of Dr. Itescu or any other member of the executive management team could impede the
achievement of our research, development and commercialization objectives.
Recruiting and retaining qualified scientific, clinical, manufacturing, regulatory affairs, sales and marketing personnel will also
be critical to our success. We may not be able to attract and retain these personnel on acceptable terms given the competition among
numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of
scientific and clinical personnel from universities and research institutions.
Our employees, principal investigators, consultants and collaboration partners may engage in misconduct or other improper
activities, including noncompliance with laws and regulatory standards and requirements and insider trading.
We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include failures to comply
with FDA regulations, to provide accurate information to the FDA, to comply with manufacturing standards we have established, to
comply with federal and state healthcare fraud and abuse laws and regulations, to report financial information or data accurately or to
disclose unauthorized activities to us. In particular, sales, marketing and business arrangements (including arrangements with
healthcare providers, opinion leaders, research institutions, distributors and payors) in the healthcare industry are subject to extensive
laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations restrict
or prohibit a wide range of activity relating to pricing, discounting, marketing and promotion, sales commissions, customer incentive
programs and other business arrangements. Employee misconduct could also involve the improper use of information obtained in the
course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation, or, given we are a listed
company in Australia and the United States, breach of insider trading or other securities laws and regulations. It is not always possible
to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in
controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits
stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not
successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the
imposition of significant fines or other sanctions.
We may acquire other companies or assets which could divert our management’s attention, result in additional dilution to our
shareholders and otherwise disrupt our operations and harm our operating results.
We have in the past and may in the future seek to acquire businesses, products or technologies that we believe could
complement or expand our product offerings, enhance our technical capabilities or otherwise offer growth opportunities. For example,
we acquired MSC assets from Osiris Therapeutics, Inc. in 2013. The pursuit of potential acquisitions may divert the attention of
management and cause us to incur various expenses in identifying, investigating and pursuing suitable acquisitions, whether or not
they are consummated. If we acquire additional businesses, we may not be able to integrate the acquired personnel, operations and
technologies successfully, or effectively manage the combined business following the acquisition. We also may not achieve the
anticipated benefits from the acquired business due to a number of factors, including:
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incurrence of acquisition-related costs;
diversion of management’s attention from other business concerns;
unanticipated costs or liabilities associated with the acquisition;
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harm to our existing business relationships with collaborators as a result of the acquisition;
harm to our brand and reputation;
the potential loss of key employees;
use of resources that are needed in other parts of our business; and
use of substantial portions of our available cash to consummate the acquisition.
In the future, if our acquisitions do not yield expected returns, we may be required to take charges to our operating results
arising from the impairment assessment process. Acquisitions may also result in dilutive issuances of equity securities or the
incurrence of debt, which could adversely affect our operating results. In addition, if an acquired business fails to meet our
expectations, our business, results of operations and financial condition may be adversely affected.
We and our collaborators must comply with environmental laws and regulations, and failure to comply with these laws and
regulations could expose us to significant liabilities.
We and our collaborators are subject to various federal, state and local environmental laws, rules and regulations, including
those relating to the discharge of materials into the air, water and ground, the manufacture, storage, handling, use, transportation and
disposal of hazardous and biological materials, and the health and safety of employees with respect to laboratory activities required for
the development of products and technologies. In the event of contamination or injury, or failure to comply with environmental,
occupational health and safety and export control laws and regulations, it could cause an interruption of our commercialization efforts,
research and development efforts, or business operations, and we could be held liable for any resulting damages and any such liability
could exceed our assets and resources.
We work with outside scientists and their institutions in developing product candidates. These scientists may have other
commitments or conflicts of interest, which could limit our access to their expertise and harm our ability to leverage our discovery
platform.
We work with scientific advisors and collaborators at academic research institutions in connection with our product
development. These scientific advisors serve as our link to the specific pools of trial participants we are targeting in that these advisors
may:
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identify individuals as potential candidates for study;
obtain their consent to participate in our research;
perform medical examinations and gather medical histories;
conduct the initial analysis of suitability of the individuals to participate in our research based on the foregoing; and
collect data and biological samples from trial participants periodically in accordance with our study protocols.
These scientists and collaborators are not our employees, rather they serve as either independent contractors or the primary
investigators under research collaboration agreements that we have with their sponsoring academic or research institution. Such
scientists and collaborators may have other commitments that would limit their availability to us. Although our scientific advisors
generally agree not to do competing work, if an actual or potential conflict of interest between their work for us and their work for
another entity arises, we may lose their services. It is also possible that some of our valuable proprietary knowledge may become
publicly known through these scientific advisors if they breach their confidentiality agreements with us, which would cause
competitive harm to our business.
If our ability to use cumulative carry forward net operating losses is or becomes subject to certain limitations or if certain tax
incentive credits from which we may benefit expire or no longer apply to us, our business, results of operations and financial
condition may be adversely affected.
We are an Australian company subject to taxation in Australia and other jurisdictions. As of June 30, 2021, our cumulative
operating losses have a total potential tax benefit of $149.7 million at local tax rates (excluding other temporary differences). These
losses may be available for use once we are in a tax profitable position. These losses were incurred in different jurisdictions and can
only be offset against profits earned in the relevant jurisdictions. Tax losses are able to be carried forward at their nominal amount
indefinitely in Australia and in Singapore, and for up to 20 years in the U.S. as long as certain conditions are met; however, new tax
reform legislation in the United States allows for indefinite carryforward of any net operating loss arising in a tax year ending after
December 31, 2018, subject to certain conditions. In order to use these tax losses, it is necessary to satisfy certain tests and, as a result,
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we cannot assure you that the tax losses will be available to offset profits if and when we earn them. Utilization of our net operating
loss and research and development credit carryforwards in the U.S. may be subject to substantial annual limitation due to ownership
change limitations that could occur in the future generally provided by Section 382 of the Internal Revenue Code of 1986, as
amended. In addition, U.S. tax reform introduced a limitation on the amount of net operating losses arising in taxable years beginning
after December 31, 2017, that a corporation may deduct in a single tax year equal to the lesser of the available net operating loss
carryover or 80 percent of a taxpayer’s pre-net operating loss deduction taxable income. With respect to carryforward net operating
losses in the U.S. that are subject to the 20-year carry-forward limit, our carry forward net operating losses first start to expire in 2032.
In addition, we may be eligible for certain research and development tax incentive refundable credits in Australia that may
increase our available cash flow. The Australian federal government's Research and Development Tax Incentive grant is available for
eligible research and development purposes based on the filing of an annual application. The Australian government may in the future
decide to modify the requirements of, reduce the amounts of the research and development tax incentive credits available under, or
discontinue its research and development tax incentive program. For instance, the Australian government undertook a review of its
Research and Development Tax Incentive program in 2016 and in the May 2018 Federal budget announced its intention to pass certain
recommendations of the review panel into law to reduce the research and development tax incentive credits available in certain
circumstances. One of the changes announced in May 2018 was to reduce the amount of the research and development tax incentive
credits available by capping the annual refundable tax offset amount at A$4.0 million for companies with an annual aggregate
turnover of less than A$20.0 million, however, refundable tax offsets related to spend incurred on clinical trials conducted in Australia
would not be capped. If the Research and Development Tax program incentives are revoked or modified, or if we no longer qualify as
a small-medium business under the A$20.0 million turnover test or we are no longer eligible for such incentives due to other
circumstances, our business, results of operations and financial condition may be adversely affected.
Our combined worldwide turnover did not exceed A$20.0 million for the year ended June 30, 2021 making us eligible for the
refundable cash tax offset for the research and development tax incentive. However, management determined the majority of activities
were not eligible under the incentive scheme and therefore did not apply for a tax offset. We were ineligible for the refundable tax
offset for the research and development tax incentive for the year ended June 30, 2020. Consequently, no income was recognized from
the Research and Development Tax Incentive program for the years ended June 30, 2021 and 2020. There can be no assurances that
we will benefit from these incentives in the future if our annual aggregate turnover is in excess of A$20.0 million or that such tax
incentive credit programs will not be revoked or modified in any way in the future.
Taxing authorities could reallocate our taxable income within our subsidiaries, which could increase our consolidated tax liability.
We conduct operations in multiple tax jurisdictions and the tax laws of those jurisdictions generally require that the transfer
pricing between affiliated companies in different jurisdictions be the same as those between unrelated companies dealing at arms’
length, and that such prices are supported by contemporaneous documentation. While we believe that we operate in compliance with
applicable transfer pricing laws and intend to continue to do so, our transfer pricing procedures are not binding on applicable tax
authorities. If tax authorities in any of these countries were to successfully challenge our transfer pricing as not reflecting arms’ length
transactions, they could require us to adjust our transfer pricing and thereby reallocate our income to reflect these revised transfer
pricing, which could result in a higher tax liability to us, and possibly interest and penalties, and could adversely affect our business,
results of operations and financial condition.
The pharmaceutical industry is highly regulated and pharmaceutical companies are subject to various federal and state fraud and
abuse laws, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act.
Healthcare fraud and abuse regulations are complex and can be subject to varying interpretations as to whether or not a statute
has been violated. The laws that may affect our ability to operate include:
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the federal Anti-Kickback Statute which prohibits, among other things, the knowing and willful payment of remuneration
to induce or reward patient referrals, prescribing or recommendation of products, or the generation of business involving
any item or service which may be payable by the federal health care programs (e.g., drugs, supplies, or health care
services for Medicare or Medicaid patients);
the federal False Claims Act which prohibits, among other things, individuals or entities from knowingly presenting, or
causing to be presented, claims for payment for government funds (e.g., payment from Medicare or Medicaid) or
knowingly making, using, or causing to be made or used a false record or statement, material to a false or fraudulent claim
for government funds;
the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health
Information Technology for Economic and Clinical Health Act, and its implementing regulations, imposes certain
requirements relating to the privacy, security and transmission of individually identifiable health information. Among
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other things, HIPAA imposes civil and criminal liability for the wrongful access or disclosure of protected health
information;
the federal Physician Payments Sunshine Act, created under Section 6002 of the Patient Protection and Affordable Care
Act (“ACA”), as amended, requires certain manufacturers of drugs, devices, biologics and medical supplies for which
payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to
report information related to certain payments or other transfers of value made or distributed to physicians and teaching
hospitals, or to entities or individuals at the request of, or designated on behalf of, those physicians and teaching hospitals
and to report annually certain ownership and investment interests held by physicians and their immediate family members;
the FDCA, which, among other things, regulates the testing, development, approval, manufacture, promotion and
distribution of drugs, devices and biologics. The FDCA prohibits manufacturers from selling or distributing “adulterated”
or “misbranded” products. A drug product may be deemed misbranded if, among other things, (i) the product labeling is
false or misleading, fails to contain requisite information or does not bear adequate directions for use; (ii) the product is
manufactured at an unregistered facility; or (iii) the product lacks the requisite FDA clearance or approval;
the U.S. Foreign Corrupt Practices Act (“FCPA”), which prohibits corrupt payments, gifts or transfers of value to non-
U.S. officials; and
non-U.S. and U.S. state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws
which may apply to items or services reimbursed by any third-party payor, including commercial insurers.
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Any failure to comply with these laws, or the regulations adopted thereunder, could result in administrative, civil, and/or
criminal penalties, and could result in a material adverse effect on our reputation, business, results of operations and financial
condition.
The federal fraud and abuse laws have been interpreted to apply to arrangements between pharmaceutical manufacturers and a
variety of health care professionals and healthcare organizations. Although the federal Anti-Kickback Statute has several statutory
exemptions and regulatory safe harbors protecting certain common activities from prosecution, all elements of the potentially
applicable exemption or safe harbor must be met in order for the arrangement to be protected, and prosecutors have interpreted the
federal healthcare fraud statutes to attack a wide range of conduct by pharmaceutical companies. In addition, most states have statutes
or regulations similar to the federal anti-kickback and federal false claims laws, which apply to items and services covered by
Medicaid and other state programs, or, in several states, apply regardless of the payor. Administrative, civil and criminal sanctions
may be imposed under these federal and state laws.
Further, the ACA, among other things, amended the intent standard under the Anti-Kickback Statute such that a person or entity
no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. In
addition, the ACA makes clear that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute
constitutes a false or fraudulent claim under the federal False Claims Act. Any violations of these laws, or any action against us for
violation of these laws, even if we successfully defend against it, could result in a material adverse effect on our reputation, business,
results of operations and financial condition.
A failure to adequately protect private health information could result in severe harm to our reputation and subject us to
significant liabilities, each of which could have a material adverse effect on our business.
Throughout the clinical trial process, we may obtain the private health information of our trial subjects. There are a number of
state, federal and international laws protecting the privacy and security of health information and personal data. As part of the
American Recovery and Reinvestment Act 2009 (“ARRA”), Congress amended the privacy and security provisions of HIPAA. HIPAA
imposes limitations on the use and disclosure of an individual’s healthcare information by healthcare providers conducting certain
electronic transactions, healthcare clearinghouses, and health insurance plans, collectively referred to as covered entities. The HIPAA
amendments also impose compliance obligations and corresponding penalties for non-compliance on certain individuals and entities
that provide services to or perform certain functions on behalf of healthcare providers and other covered entities involving the use or
disclosure of individually identifiable health information, collectively referred to as business associates. ARRA also made significant
increases in the penalties for improper use or disclosure of an individual’s health information under HIPAA and extended enforcement
authority to state attorneys general. The amendments also create notification requirements to federal regulators, and in some cases
local and national media, for individuals whose health information has been inappropriately accessed or disclosed. Notification is not
required under HIPAA if the health information that is improperly used or disclosed is deemed secured in accordance with certain
encryption or other standards developed by the U.S. Department of Health and Human Services, or HHS. Most states have laws
requiring notification of affected individuals and state regulators in the event of a breach of personal information, which is a broader
class of information than the health information protected by HIPAA. Many state laws impose significant data security requirements,
such as encryption or mandatory contractual terms to ensure ongoing protection of personal information. Activities outside of the U.S.
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implicate local and national data protection standards, impose additional compliance requirements and generate additional risks of
enforcement for non-compliance. The EU’s General Data Protection Regulation, Canada’s Personal Information Protection and
Electronic Documents Act and other data protection, privacy and similar national, state/provincial and local laws and regulations may
also restrict the access, use and disclosure of patient health information abroad. We may be required to expend significant capital and
other resources to ensure ongoing compliance with applicable privacy and data security laws, to protect against security breaches and
hackers or to alleviate problems caused by such breaches, and the failure to so comply may lead to fines or penalties.
Our operations are subject to anti-corruption laws, including Australian bribery laws, the United Kingdom Bribery Act, and the
FCPA and other anti-corruption laws that apply in countries where we do business.
Anti-corruption laws generally prohibit us and our employees and intermediaries from bribing, being bribed or making other
prohibited payments to government officials or other persons to obtain or retain business or gain some other business advantage.
Although we believe that we have adequate policies and enforcement mechanisms to ensure legal and regulatory compliance with the
FCPA, the U.K. Bribery Act 2010 and other similar regulations, we participate in collaborations and relationships with third parties,
and it is possible that any of our employees, subcontractors, agents or partners may violate any such legal and regulatory requirements,
which may expose us to criminal or civil enforcement actions, including penalties and suspension or disqualification from U.S. federal
procurement contracting. In addition, we cannot predict the nature, scope or effect of future regulatory requirements to which our
international operations might be subject or the manner in which existing laws might be administered or interpreted.
There is no assurance that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws or
other laws including trade related laws. If we are not in compliance with these laws, we may be subject to criminal and civil penalties,
disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business,
financial condition, results of operations and liquidity. Likewise, any investigation of any potential violations of these laws by
respective government bodies could also have an adverse impact on our reputation, our business, results of operations and financial
condition.
We may lose our foreign private issuer status, which would then require us to comply with the Exchange Act’s domestic reporting
regime and cause us to incur additional legal, accounting and other expenses.
In order to maintain our current status as a foreign private issuer, either (1) a majority of our ordinary shares must be either
directly or indirectly owned of record by non-residents of the United States or (2) (a) a majority of our executive officers or directors
must not be U.S. citizens or residents, (b) more than 50 percent of our assets cannot be located in the U.S. and (c) our business must be
administered principally outside the U.S. If we lost this status, we would be required to comply with the Exchange Act reporting and
other requirements applicable to U.S. domestic issuers, which are more detailed and extensive than the requirements for foreign
private issuers. We may also be required to make changes in our corporate governance practices in accordance with various SEC rules
and Nasdaq listing standards. Further, we would be required to comply with U.S. GAAP, as opposed to IFRS, in the preparation and
issuance of our financial statements for historical and current periods. The regulatory and compliance costs to us under U.S. securities
laws if we are required to comply with the reporting requirements applicable to a U.S. domestic issuer may be higher than the cost we
would incur as a foreign private issuer. As a result, we expect that a loss of foreign private issuer status would increase our legal and
financial compliance costs.
If we fail to maintain proper internal controls, our ability to produce accurate financial statements or comply with applicable
regulations could be impaired.
Section 404(a) of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”) requires that our management assess and report
annually on the effectiveness of our internal controls over financial reporting and identify any material weaknesses in our internal
controls over financial reporting. In order to maintain and improve the effectiveness of our disclosure controls and procedures and
internal control over financial reporting, we have expended, and anticipate that we will continue to expend, significant resources,
including accounting-related costs and significant management oversight.
If either we are unable to conclude that we have effective internal controls over financial reporting or our independent auditors
are unwilling or unable to provide us with an unqualified report on the effectiveness of our internal controls over financial reporting as
required by Section 404(b) of the Sarbanes-Oxley Act, investors may lose confidence in our operating results, the price of the ADSs
could decline and we may be subject to litigation or regulatory enforcement actions. In addition, if we are unable to meet the
requirements of Section 404 of the Sarbanes-Oxley Act, we may not be able to remain listed on Nasdaq Global Select Market
(“Nasdaq”).
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We have incurred and will continue to incur significant increased costs as a result of operating as a company whose ADSs are
publicly traded in the United States, and our management will continue to be required to devote substantial time to compliance
initiatives.
As a company whose ADSs are publicly traded in the United States, we have incurred and will continue to incur significant
legal, accounting, insurance and other expenses. The Sarbanes-Oxley Act, Dodd-Frank Wall Street Reform and Consumer Protection
Act and related rules implemented by the SEC and Nasdaq, have imposed various requirements on public companies including
requiring establishment and maintenance of effective disclosure and financial controls. Our management and other personnel will need
to continue to devote a substantial amount of time to these compliance initiatives, and we will need to add additional personnel and
build our internal compliance infrastructure. Moreover, these rules and regulations have increased and will continue to increase our
legal and financial compliance costs and will make some activities more time-consuming and costly. These laws and regulations could
also make it more difficult and expensive for us to attract and retain qualified persons to serve on our board of directors, our board
committees or as our senior management. Furthermore, if we are unable to satisfy our obligations as a public company, we could be
subject to delisting of the ADSs, fines, sanctions and other regulatory action and potentially regulatory investigations and enforcement
and/or civil litigation.
We have never declared or paid dividends on our ordinary shares, and we do not anticipate paying dividends in the foreseeable
future. Therefore, you must rely on price-appreciation of our ordinary shares or ADSs for a return on your investment.
We have never declared or paid cash dividends on our ordinary shares. For the foreseeable future, we currently intend to retain
all available funds and any future earnings to support our operations and to finance the growth and development of our business. Any
future determination to declare cash dividends will be made at the discretion of our board of directors, subject to compliance with
applicable laws and covenants under the loan facilities with Hercules and NovaQuest or other current or future credit facilities, which
may restrict or limit our ability to pay dividends, and will depend on our financial condition, operating results, capital requirements,
general business conditions and other factors that our board of directors may deem relevant. We do not anticipate paying any cash
dividends on our ordinary shares in the foreseeable future. As a result, a return on your investment in our ordinary shares or ADSs will
likely only occur if our ordinary share or ADS price appreciates. There is no guarantee that our ordinary shares or ADSs will
appreciate in value in the future.
Australian takeover laws may discourage takeover offers being made for us or may discourage the acquisition of a significant
position in our ordinary shares or ADSs.
We are incorporated in Australia and are subject to the takeover laws of Australia. Among other things, we are subject to the
Australian Corporations Act 2001 (the “Corporations Act”). Subject to a range of exceptions, the Corporations Act prohibits the
acquisition of a direct or indirect interest in our issued voting shares if the acquisition of that interest will lead to a person’s voting
power in us increasing to more than 20%, or increasing from a starting point that is above 20% and below 90%. Australian takeover
laws may discourage takeover offers being made for us or may discourage the acquisition of a significant position in our ordinary
shares. This may have the ancillary effect of entrenching our board of directors and may deprive or limit our shareholders’ opportunity
to sell their ordinary shares or ADSs and may further restrict the ability of our shareholders to obtain a premium from such
transactions.
Significant disruptions of information technology systems, data security breaches or unauthorized disclosure of sensitive data
could adversely affect our business by exposing us to liability and affect our business and reputation.
The Company is increasingly dependent on critical, complex, and interdependent information technology systems (IT systems),
including cloud based software and external servers, some of which are managed or hosted by third parties, to support business
processes as well as internal and external communications. The information and data processed and stored in our IT systems, and
those of our research collaborators, CROs, contract manufacturers, suppliers, distributors, or other third parties for which we depend
to operate our business, may be vulnerable to cybersecurity breaches from unauthorized activity by our employees, contractors or
malware, hacking, business email compromise, phishing or other cyberattacks directed by other parties. Such breaches can result in
loss, damage, denial-of-service, unauthorized access or misappropriation and may pose a risk that sensitive data, including our
intellectual property, trade secrets or personal information of our employees, patients, customers or other business partners may be
exposed to unauthorized persons or to the public. In addition, our increased reliance on personnel working from home may negatively
impact productivity, or disrupt, delay, or otherwise adversely impact our business. The increase in working remotely could increase
our cybersecurity risk, create data accessibility concerns, and make us more susceptible to communication disruptions, any of which
could adversely impact our business operations or delay necessary interactions with local and federal regulators, manufacturing sites,
clinical trial sites, and other third parties.
The rapidly moving nature of technology and the increasing sophistication of cybersecurity threats, may mean our measures to
prevent, respond to and minimize such risks may be ineffective. If a material incident or interruption were to occur, it could result in a
35
disruption of our development programs and future commercial operations, including due to a loss, corruption or unauthorized
disclosure of our proprietary or sensitive information. Additionally, the costs to the company to investigate and mitigate cybersecurity
incidents could be significant. Any disruption, security breach, or action by the company, its employees, or contractors that might be
inconsistent with the rapidly evolving data privacy and security laws and regulations applicable within Australia and the United States
and elsewhere where we conduct business, could result in; enforcement actions by both countries state and federal governments or
foreign governments, liability or sanctions under data privacy laws including healthcare laws such as the Privacy Act or HIPAA that
protect certain types of sensitive information, regulatory penalties, other legal proceedings such as but not limited to private litigation,
the incurrence of significant remediation costs, disruptions to our development programs, business operations and collaborations,
diversion of management efforts and damage to our reputation which could harm our business and operations.
Risks Related to Our Trading Markets
The market price and trading volume of our ordinary shares and ADSs may be volatile and may be affected by economic
conditions beyond our control. Such volatility may lead to securities litigation.
The market price of our ordinary shares and ADSs may be highly volatile and subject to wide fluctuations. In addition, the
trading volume of our ordinary shares and ADSs may fluctuate and cause significant price variations to occur. We cannot assure you
that the market price of our ordinary shares and ADSs will not fluctuate or significantly decline in the future.
Some specific factors that could negatively affect the price of our ordinary shares and ADSs or result in fluctuations in their
price and trading volume include:
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•
•
•
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•
•
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results of clinical trials of our product candidates;
results of clinical trials of our competitors’ products;
regulatory actions with respect to our products or our competitors’ products;
actual or anticipated fluctuations in our quarterly operating results or those of our competitors;
publication of research reports by securities analysts about us or our competitors in the industry;
our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give
to the market;
fluctuations of exchange rates between the U.S. dollar and the Australian dollar;
additions to or departures of our key management personnel;
issuances by us of debt or equity securities;
litigation or investigations involving our company, including: shareholder litigation; investigations or audits by regulators
into the operations of our company; or proceedings initiated by our competitors or clients;
strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic
investments or changes in business strategy;
the passage of legislation or other regulatory developments affecting us or our industry;
fluctuations in the valuation of companies perceived by investors to be comparable to us;
changes in trading volume of ADSs on the Nasdaq and of our ordinary shares on the ASX;
sales or perceived potential sales of the ADSs or ordinary shares by us, our directors, senior management or our
shareholders in the future;
short selling or other market manipulation activities;
announcement or expectation of additional financing efforts;
terrorist acts, acts of war or periods of widespread civil unrest;
natural disasters and other calamities;
changes in market conditions for biopharmaceutical companies; and
conditions in the U.S. or Australian financial markets or changes in general economic conditions.
In the past, following periods of volatility in the market price of a company’s securities, shareholders often instituted securities
class action litigation against that company. If we were involved in a class action suit, it could divert the attention of senior
36
management, require significant expenditure for defense costs, and, if adversely determined, could have a material adverse effect on
our results of operations and financial condition. In October 2020, in light of the Complete Response Letter released by the FDA and
the decline in the market price of our ADSs, a purported class action lawsuit was filed in the U.S. Federal District Court for the
Southern District of New York on behalf of purchasers or acquirers of our ADSs against our Company, our Chief Executive Officer,
its Chief Financial Officer and its Chief Medical Officer for alleged violations of the U.S. Securities Exchange Act of 1934. We will
vigorously defend this and any other similarly-based litigation should it arise. We cannot provide any assurance as to the possible
outcome or cost to us from the lawsuit, particularly as it is at an early stage, nor how long it may take to resolve lawsuit.
The dual listing of our ordinary shares and the ADSs may adversely affect the liquidity and value of these securities.
Our ADSs are listed on the Nasdaq and our ordinary shares are listed on the ASX. We cannot predict the effect of this dual
listing on the value of our ordinary shares and ADSs. However, the dual listing of our ordinary shares and ADSs may dilute the
liquidity of these securities in one or both markets and may adversely affect the development of an active trading market for the ADSs
in the United States. The price of the ADSs could also be adversely affected by trading in our ordinary shares on the ASX, and vice
versa.
If securities or industry analysts do not publish research reports about our business, or if they issue an adverse opinion about our
business, the market price and trading volume of our ordinary shares and/or ADSs could decline.
The trading market for our ordinary shares and ADSs could be influenced by the research and reports that securities or industry
analysts publish about us or our business. Securities and industry analysts may discontinue research on our company, to the extent
such coverage currently exists, or in other cases, may never publish research on our company. If too few securities or industry analysts
commence coverage of our company, the trading price for our ordinary shares and ADSs would likely be negatively impacted. If one
or more of the analysts who cover us downgrade our ordinary shares or ADSs or publish inaccurate or unfavorable research about our
business, the market price of our ADSs would likely decline. If one or more of these analysts cease coverage of our company or fail to
publish reports on us regularly, demand for our ordinary shares and/or ADSs could decrease, which might cause our price and trading
volume to decline.
Risks Related to Ownership of Our ADSs
An active trading market for the ADSs may not develop in the United States.
Our ADSs are listed in the United States on the Nasdaq under the symbol “MESO.” However, we cannot assure you that an
active public market in the United States for the ADSs will develop on that exchange, or if developed, that this market will be
sustained.
We currently report our financial results under IFRS, which differs in certain significant respect from U.S. GAAP.
Currently we report our financial statements under IFRS. There have been and there may in the future be certain significant
differences between IFRS and U.S. GAAP, including differences related to revenue recognition, intangible assets, share-based
compensation expense, income tax and earnings per share. As a result, our financial information and reported earnings for historical or
future periods could be significantly different if they were prepared in accordance with U.S. GAAP. In addition, we do not intend to
provide a reconciliation between IFRS and U.S. GAAP unless it is required under applicable law. As a result, you may not be able to
meaningfully compare our financial statements under IFRS with those companies that prepare financial statements under U.S. GAAP.
As a foreign private issuer, we are permitted and expect to follow certain home country corporate governance practices in lieu of
certain Nasdaq requirements applicable to domestic issuers and we are permitted to file less information with the Securities and
Exchange Commission than a company that is not a foreign private issuer. This may afford less protection to holders of our ADSs.
As a “foreign private issuer”, as defined in Rule 405 under the Securities Exchange Act of 1933, as amended (the “Securities
Act”), whose ADSs will be listed on the Nasdaq, we will be permitted to, and plan to, follow certain home country corporate
governance practices in lieu of certain Nasdaq requirements. For example, we may follow home country practice with regard to
certain corporate governance requirements, such as the composition of the board of directors and quorum requirements applicable to
shareholders’ meetings. This difference may result in a board that is more difficult to remove and less shareholder approvals required
generally. In addition, we may follow home country practice instead of the Nasdaq Global Select Market requirement to hold
executive sessions and to obtain shareholder approval prior to the issuance of securities in connection with certain acquisitions or
private placements of securities. The above differences may result in less shareholder oversight and requisite approvals for certain
acquisition or financing related decisions. Further, we may follow home country practice instead of the Nasdaq Global Select Market
requirement to obtain shareholder approval prior to the establishment or amendment of certain share option, purchase or other
compensation plans. This difference may result in less shareholder oversight and requisite approvals for certain company
37
compensation related decisions. A foreign private issuer must disclose in its annual reports filed with the Securities and Exchange
Commission, or SEC, and the Nasdaq Global Select Market, the requirements with which it does not comply followed by a description
of its applicable home country practice. The Australian home country practices described above may afford less protection to holders
of the ADSs than that provided under the Nasdaq Global Select Market rules.
Further, as a foreign private issuer, we are exempt from certain rules under the “Exchange Act”, that impose disclosure
requirements as well as procedural requirements for proxy solicitations under Section 14 of the Exchange Act. In addition, our
officers, directors and principal shareholders are exempt from the reporting and “short-swing” profit recovery provisions of Section 16
of the Exchange Act. Moreover, we are not required to file periodic reports and financial statements with the SEC as frequently or as
promptly as a company that files as a domestic issuer whose securities are registered under the Exchange Act, nor are we generally
required to comply with the SEC’s Regulation FD, which restricts the selective disclosure of material non-public information.
Accordingly, the information may not be disseminated in as timely a manner, or there may be less information publicly available
concerning us generally than there is for a company that files as a domestic issuer.
ADS holders may be subject to additional risks related to holding ADSs rather than ordinary shares.
ADS holders do not hold ordinary shares directly and, as such, are subject to, among others, the following additional risks.
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As an ADS holder, we will not treat you as one of our shareholders and you will not be able to exercise shareholder rights,
except through the American depositary receipt, or ADR, depositary as permitted by the deposit agreement.
Distributions on the ordinary shares represented by your ADSs will be paid to the ADR depositary, and before the ADR
depositary makes a distribution to you on behalf of your ADSs, any withholding taxes that must be paid will be deducted.
Additionally, if the exchange rate fluctuates during a time when the ADR depositary cannot convert the foreign currency,
you may lose some or all of the value of the distribution.
We and the ADR depositary may amend or terminate the deposit agreement without the ADS holders’ consent in a
manner that could prejudice ADS holders.
ADS holders must act through the ADR depositary to exercise your voting rights and, as a result, you may be unable to exercise
your voting rights on a timely basis.
As a holder of ADSs (and not the ordinary shares underlying your ADSs), we will not treat you as one of our shareholders, and
you will not be able to exercise shareholder rights. The ADR depositary will be the holder of the ordinary shares underlying your
ADSs, and ADS holders will be able to exercise voting rights with respect to the ordinary shares represented by the ADSs only in
accordance with the deposit agreement relating to the ADSs. There are practical limitations on the ability of ADS holders to exercise
their voting rights due to the additional procedural steps involved in communicating with these holders. For example, holders of our
ordinary shares will receive notice of shareholders’ meetings by mail or email and will be able to exercise their voting rights by either
attending the shareholders meeting in person or voting by proxy. ADS holders, by comparison, will not receive notice directly from
us. Instead, in accordance with the deposit agreement, we will provide notice to the ADR depositary of any such shareholders meeting
and details concerning the matters to be voted upon. As soon as practicable after receiving notice from us of any such meeting, the
ADR depositary will mail to holders of ADSs the notice of the meeting and a statement as to the manner in which voting instructions
may be given by ADS holders. To exercise their voting rights, ADS holders must then instruct the ADR depositary as to voting the
ordinary shares represented by their ADSs. Due to these procedural steps involving the ADR depositary, the process for exercising
voting rights may take longer for ADS holders than for holders of ordinary shares. The ordinary shares represented by ADSs for which
the ADR depositary fails to receive timely voting instructions will not be voted. Under Australian law and our Constitution, any
resolution to be considered at a meeting of the shareholders shall be decided on a show of hands unless a poll is demanded by the
shareholders at or before the declaration of the result of the show of hands. Under voting by a show of hands, multiple “yes” votes by
ADS holders will only count as one “yes” vote and will be negated by a single “no” vote, unless a poll is demanded.
If we are or become classified as a passive foreign investment company, our U.S. securityholders may suffer adverse tax
consequences.
Based upon an analysis of our income and assets for the taxable year ended June 30, we do not believe we were a passive
foreign investment company (a "PFIC") for our most recent tax year. In general, if at least 75% of our gross income for any taxable
year consists of passive income or at least 50% of the average quarterly value of assets is attributable to assets that produce passive
income or are held for the production of passive income, including cash, then we will be classified as a PFIC for U.S. federal income
tax purposes. Passive income for this purpose generally includes dividends, interest, certain royalties and rents, and gains from
commodities and securities transactions. Passive assets for this purpose generally includes assets held for the production of passive
income. Accordingly, passive assets generally include any cash, cash equivalents and cash invested in short-term, interest bearing,
debt instruments or bank deposits that are readily convertible into cash. Since PFIC status depends upon the composition of our
38
income and assets and the market value of our assets from time to time, and since the determination of PFIC status must be made
annually at the end of each taxable year, there can be no assurance that we will not be considered a PFIC for any future taxable year.
Investors should be aware that our gross income for purposes of the PFIC income test depends on the receipt of active revenue, and
there can be no assurances that such active revenue will continue, or that we will receive other gross income that is not considered
passive for purposes of the PFIC income test. If we were a PFIC for any taxable year during a U.S. investor’s holding period for the
ordinary shares or ADSs, we would ordinarily continue to be treated as a PFIC for each subsequent year during which the U.S.
investor owned the ordinary shares or ADSs. If we were treated as a PFIC, U.S. investors would be subject to special punitive tax
rules with respect to any "excess distribution" received from us and any gain realized from a sale or other disposition (including a
pledge) of the ordinary shares or ADSs unless a U.S. investor made a timely "qualified electing fund" or "mark-to-market" election.
For a more detailed discussion of the U.S. tax consequences to U.S. investors if we were classified as a PFIC, see Item 10.E-
"Taxation — Certain Material U.S. Federal Income Tax Considerations to U.S. Holders — Passive Foreign Investment Company".
Changes in foreign currency exchange rates could impact amounts you receive as a result of any dividend or distribution we
declare on our ordinary shares.
Any significant change in the value of the Australian dollar may impact amounts you receive in U.S. dollars as a result of any
dividend or distribution we declare on our ordinary shares as a holder of our ADSs. More specifically, any dividends that we pay on
our ordinary shares will be in Australian dollars. The depositary for the ADSs has agreed to pay to you the cash dividends or other
distributions it or the custodian receives on our ordinary shares or other deposited securities after deducting its fees and expenses,
including any such fees or expenses incurred to convert any such Australian dollars into U.S. dollars. You will receive these
distributions in U.S. dollars in proportion to the number of our ordinary shares your ADSs represent. Depreciation of the U.S. dollar
against the Australian dollar would have a negative effect on any such distribution payable to you.
You may not receive distributions on our ordinary shares represented by the ADSs or any value for such distribution if it is illegal
or impractical to make them available to holders of ADSs.
While we do not anticipate paying any dividends on our ordinary shares in the foreseeable future, if such a dividend is declared,
the depositary for the ADSs has agreed to pay to you the cash dividends or other distributions it or the custodian receives on our
ordinary shares or other deposited securities after deducting its fees and expenses. You will receive these distributions in proportion to
the number of our ordinary shares your ADSs represent. However, in accordance with the limitations set forth in the deposit
agreement, it may be unlawful or impractical to make a distribution available to holders of ADSs. We have no obligation to take any
other action to permit the distribution of the ADSs, ordinary shares, rights or anything else to holders of the ADSs. This means that
you may not receive the distributions we make on our ordinary shares or any value from them if it is unlawful or impractical to make
them available to you. These restrictions may have a material adverse effect on the value of your ADSs.
You may be subject to limitations on transfers of your ADSs.
ADSs are transferable on the books of the depositary. However, the depositary may close its transfer books at any time or from
time to time when it deems expedient in connection with the performance of its duties. In addition, the depositary may refuse to
deliver, transfer or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if we
or the depositary deems it advisable to do so because of any requirement of law or of any government or governmental body, or under
any provision of the deposit agreement, or for any other reason.
U.S. investors may have difficulty enforcing civil liabilities against our company, our directors or members of our senior
management.
Several of our officers and directors are non-residents of the United States, and a substantial portion of the assets of such
persons are located outside the U.S. As a result, it may be impossible to serve process on such persons in the United States or to
enforce judgments obtained in U.S. courts against them based on civil liability provisions of the securities laws of the U.S. Even if you
are successful in bringing such an action, there is doubt as to whether Australian courts would enforce certain civil liabilities under
U.S. securities laws in original actions or judgments of U.S. courts based upon these civil liability provisions. In addition, awards of
punitive damages in actions brought in the U.S. or elsewhere may be unenforceable in Australia or elsewhere outside the U.S. An
award for monetary damages under the U.S. securities laws would be considered punitive if it does not seek to compensate the
claimant for loss or damage suffered and is intended to punish the defendant. The enforceability of any judgment in Australia will
depend on the particular facts of the case as well as the laws and treaties in effect at the time. The U.S. and Australia do not currently
have a treaty or statute providing for recognition and enforcement of the judgments of the other country (other than arbitration awards)
in civil and commercial matters. As a result, our public shareholders and holders of the ADSs may have more difficulty in protecting
their interests through actions against us, our management, our directors than would shareholders of a corporation incorporated in a
jurisdiction in the United States.
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Item 4.
Information on the Company
4.A
History and Development of Mesoblast
Mesoblast Limited
Mesoblast Limited was incorporated on June 8, 2004 as a public company in Australia under the Corporations Act 2001 with an
indefinite duration. On December 16, 2004 we became listed on the Australian Securities Exchange (the “ASX”). On November 13,
2015, we became listed on the Nasdaq Global Select Market (“Nasdaq”) and from this date we have been dual-listed in Australia and
the United States. Our registered office is located at the following address:
Mesoblast Ltd
Level 38
55 Collins Street
Melbourne VIC 3000
Australia
Telephone: +61 3 9639 6036
Web: www.mesoblast.com
Our agent for service of process in the United States is Mesoblast Inc., 505 Fifth Avenue, Level 3, New York, NY 10017. All
information we file with the SEC is available through the SEC's Electronic Data Gathering, Analysis and Retrieval system, which may
be accessed through the SEC's website at www.sec.gov.
For a list of our significant subsidiaries, see Exhibit 8.1 to this Annual Report.
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Important Corporate Developments
Fiscal year 2021 to date of annual report
August
July
May
April
March
Announced Chief Financial Officer (CFO) Josh Muntner will be leaving the organization and Andrew Chaponnel,
currently Head of Finance, will assume the role of interim CFO, effective August 31, 2021.
90 day survival outcomes from the randomized controlled trial of remestemcel-L in 222 ventilator-dependent COVID-19
patients with moderate/severe acute respiratory distress syndrome (“ARDS”) were highlighted at the International Society
for Cell & Gene Therapy (ISCT) Scientific Signatures Series event on Cell and Gene-Based Therapies in Lung Diseases
and Critical Illnesses
Provided an update on the strategy for potential approval pathways for rexlemestrocel-L in the United States (US) with
chronic low back pain (“CLBP”) due to degenerative disc disease refractory to available therapies, including filing a
request for a Type C meeting with the United States Food and Drug Administration (“FDA”) and an amended
collaboration agreement with its partner in Europe and Latin America, Grünenthal.
The peer-reviewed journal Respiratory Research published results showing respiratory and functional clinical outcomes in
patients with chronic obstructive pulmonary disease and elevated levels of the inflammatory biomarker C-reactive protein
treated with Mesoblast’s mesenchymal stromal cell (“MSC”) product candidate remestemcel-L.
Announced results from the randomized controlled trial of remestemcel-L in 222 ventilator-dependent COVID-19 patients
with moderate to severe acute respiratory distress syndrome (“ARDS”).
Philip J. Facchina joined the Board of Directors. Mr Facchina is Chief Strategy Officer of SurgCenter Development, one
of the largest private operators of ambulatory surgical centers in the US specializing in spine, orthopaedic and total joint
procedures.
Successful completion of an A$138.0 million (US$110.0 million) private placement led by a strategic US investor group
through the placement of 60.1 million new fully-paid ordinary shares at a price of A$2.30. The investors also received
warrants to acquire a further 15 million shares at a price of A$2.88 per share, a 25% premium to the placement price,
which may raise up to a further A$43.2 million, on or before March 15, 2028.
February
Pediatrics (Journal of the American Academy of Pediatrics) published a paper on the first two children treated with
Mesoblast’s MSC product candidate remestemcel-L for life-threatening multisystem inflammatory syndrome (“MIS-C”)
associated with COVID-19.
Announced the results from the Phase 3 randomized controlled trial of our allogeneic mesenchymal precursor cell
(“MPC”) therapy rexlemestrocel-L in 404 enrolled patients with CLBP due to degenerative disc disease (“DDD”)
refractory to conventional treatments.
January
Dr Silviu Itescu presented additional data from the DREAM-HF Phase 3 trial in patients with chronic heart failure at the
H.C. Wainwright Virtual BioConnect 2021 Conference.
Announced additional results from the DREAM-HF randomized controlled Phase 3 trial in 537 treated patients with
chronic heart failure with reduced left ventricular ejection fraction (“HFrEF”) who received rexlemestrocel-L or control
sham.
December Following the third interim analysis on the first 180 patients in the randomized controlled trial of remestemcel-L in
ventilator-dependent patients with moderate to severe ARDS due to COVID-19 infection, the Data Safety Monitoring
Board (DSMB) recommended that the trial complete with the currently enrolled 223 patients, and that all be followed-up
as planned.
Announced the top-line results from the DREAM-HF Phase 3 randomized controlled trial of its allogeneic cell therapy
rexlemestrocel-L in 537 patients with advanced chronic heart failure.
The FDA granted Fast Track designation for remestemcel-L in the treatment of ARDS due to COVID-19 infection. Fast
Track designation is granted if a therapy demonstrates the potential to address unmet medical needs for a serious or life-
threatening disease. ARDS is the primary cause of death in patients with COVID-19.
November Announced we had entered into a license and collaboration agreement with Novartis for the development, manufacture,
and commercialization of remestemcel-L, with an initial focus on the treatment of ARDS including that associated with
COVID-19. The agreement remains subject to certain closing conditions, including time to analyze the results from the
COVID-19 ARDS trial.
October
A randomized, controlled study of remestemcel-L delivered by an endoscope directly to the areas of inflammation and
tissue injury in up to 48 patients with medically refractory Crohn’s disease and ulcerative colitis commenced at Cleveland
Clinic.
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The FDA issued a Complete Response Letter to the Company’s Biologics License Application (“BLA”) for RYONCIL™
(“RYONCIL”) in pediatric patients with steroid-refractory acute graft versus host disease (“SR-aGVHD”). Despite the
overwhelming Oncologic Drugs Advisory Committee (“ODAC”) of the FDA vote in August 2020, the FDA
recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children to
provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD.
September Remestemcel-L was selected as the winner of the Fierce Innovation Awards - Life Sciences Edition 2020 for Biotech
Innovation.
The independent DSMB recommended continuation of the Phase 3 trial of remestemcel-L in patients with ARDS due to
COVID-19 infection, following completion of the trial’s first interim analysis.
Received ethics approval to include Australian hospitals in the Phase 3 randomized controlled trial of remestemcel-L in
ventilator-dependent COVID-19 patients with ARDS.
August
The ODAC voted overwhelmingly in favor that available data support the efficacy of RYONCIL in pediatric patients with
SR-aGVHD. The ODAC is an independent panel of experts that evaluates efficacy and safety of data and makes
appropriate recommendations to the FDA.
July
Appointment of Dagmar Rosa-Bjorkeson to the role of Chief Operating Officer. Her responsibilities include managing
commercial operations, leading the business units, building out key strategic alliances, and overseeing product launches.
An Expanded Access Protocol was initiated in the United States for compassionate use of remestemcel-L in the treatment
of COVID-19 infected children with cardiovascular and other complications of MIS-C. MIS-C is a life-threatening
complication of COVID-19 in otherwise healthy children and adolescents that includes massive simultaneous
inflammation of multiple critical organs and their vasculature.
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4.B
Business Overview
Mesoblast has developed a range of late stage product candidates derived from our first and second generation proprietary
mesenchymal lineage cell therapy technology platforms.
Remestemcel-L is our first generation mesenchymal lineage stromal cell product platform and is in late stage development for
treatment of systemic inflammatory diseases including:
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Pediatric steroid refractory acute Graft versus Host Disease (SR-aGVHD);
Acute respiratory distress syndrome (ARDS); and
Biologic refractory inflammatory bowel disease.
Rexlemestrocel-L is our second generation mesenchymal lineage precursor cell product platform and is in late stage
development for treatment of:
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Advanced chronic heart failure (CHF); and
Chronic low back pain (CLBP) due to degenerative disc disease.
Both platforms have life cycle management strategies with promising emerging pipelines.
The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines.
These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide upon
receiving marketing authorizations.
Mesoblast’s immuno-selected, culture expanded cellular medicines are based on mesenchymal precursor cells (“MPCs”) and
their progeny, MSCs. These are rare cells (approximately 1:100,000 in bone marrow) found around blood vessels that are central to
blood vessel maintenance, repair and regeneration. These cells have a unique immunological profile with immunomodulatory effects
that reduce inflammation allowing healing and repair. This mechanism of action enables the targeting of multiple disease pathways
across a wide spectrum of complex diseases with significant unmet medical needs.
Mesenchymal lineage cells are collected from the bone marrow of healthy adult donors and proprietary processes are utilized to
expand them to a uniform, well characterized, and highly reproducible cell population. This enables manufacturing at industrial scale
for commercial purposes. Another key feature of Mesoblast’s cells is they can be administered to patients without the need for donor–
recipient matching or recipient immune suppression.
Mesoblast’s approach to product development is to ensure rigorous scientific investigations are performed with well-
characterized cell populations in order to understand mechanisms of action for each potential indication. Extensive preclinical
translational studies guide clinical trials that are structured to meet stringent safety and efficacy criteria set by international regulatory
agencies. All trials are conducted under the continuing review of independent Data Safety Monitoring Boards comprised of
independent medical experts and statisticians. These safeguards are intended to ensure the integrity and reproducibility of results, and
to ensure that outcomes observed are scientifically reliable.
Allogeneic, Off-the-Shelf, Commercially Scalable Products
Our technology platform enables development of a diverse range of products derived from the mesenchymal cell lineage in adult
tissues. MPCs constitute the earliest known cell type in the mesenchymal lineage in vivo.
MPCs can be isolated using monoclonal antibodies and culture-expanded using methods that enable efficient expansion without
differentiation. MSCs are defined biologically in culture following density gradient separation from other tissue cell types and
following culture by plastic adherence. MSCs presumably represent culture-expanded in-vitro progeny of the undifferentiated MPCs
present in-vivo. The functional characteristics of each cell type enable product development for specific indications.
Our proprietary mesenchymal lineage cell-based products have distinct biological characteristics enabling their use for
allogeneic purposes.
Immune Privilege: Mesenchymal lineage cells are immune privileged, in that they do not express specific cell surface co-
stimulatory molecules that initiate immune allogeneic responses.
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Expansion: We have developed proprietary methods that enable the large scale expansion of our cells while maintaining their
ability to produce the key biomolecules associated with tissue health and repair. This allows us to produce a cellular product intended
to demonstrate consistent and well-defined characterization and activity.
In contrast, autologous cell therapy products, which are produced from the patient’s own cells, require individual product
regulatory testing and do not benefit from manufacturing economies of scale. Moreover, autologous therapies may be vulnerable to
significant patient-to-patient variability.
Products Commercialized by Licensees
Two allogeneic mesenchymal stromal cell (MSC) products developed and commercialized by Mesoblast licensees have been
approved in Japan and Europe, with both licensees the first to receive full regulatory approval for an allogeneic cellular medicine in
these major markets.
Mesoblast’s licensee in Japan, JCR, is marketing its MSC-based product in Japan for the treatment of aGVHD in children and
adults. TEMCELL was the first allogeneic cellular medicine to receive full regulatory approval in Japan. Mesoblast receives royalty
income on sales of TEMCELL in Japan.
In 2017, Mesoblast granted TiGenix, now a wholly owned subsidiary of Takeda, exclusive access to certain of its patents to
support global commercialization of Alofisel®, previously known as Cx601, the first allogeneic MSC therapy to receive central
marketing authorization approval from the European Commission. Mesoblast receives royalty income on Takeda’s worldwide sales of
Alofisel® in the local treatment of perianal fistulae.
Mesoblast Product Candidates
Remestemcel-L (RYONCILTM) for the Treatment of Steroid Refractory Acute Graft Versus Host Disease
Overview
Remestemcel-L (RYONCIL) is an intravenously delivered product candidate for the treatment of steroid-refractory acute graft
versus host disease, or SR-aGVHD, following an allogeneic bone marrow transplant.
In a bone marrow transplant, donor cells can attack the recipient, causing GVHD. The donor T-cell mediated inflammatory
response involves secretion of TNF-alpha and IFN-gamma, resulting in activation of pro-inflammatory T-cells and tissue damage in
the skin, gut and liver, which can be fatal.
Remestemcel-L is suggested to have immunomodulatory properties to counteract the cytokine storms that are implicated in
various inflammatory conditions. The mechanism of action is thought to involve down-regulating the production of pro-inflammatory
cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory
cells to involved tissues.
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This life-threatening disease occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT).
Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these
numbers are increasing. In patients with the most severe form of SR-aGVHD (Grade C/D or III/IV) mortality can be as high as 90%
despite optimal best available therapy. There are currently no FDA-approved treatments in the United States for children under 12
with SR-aGVHD.
Current Status and Anticipated Milestones
Mesoblast submitted its completed BLA to the FDA for remestemcel-L in January 2020. The BLA was subsequently accepted
for priority review by the FDA on March 30, 2020, with a PDUFA action date set for September 30, 2020. In August 2020, the ODAC
to the FDA voted overwhelmingly in favor (nine to one(1)) that the available data support the efficacy of remestemcel-L in pediatric
patients with SR-aGVHD. FDA issued a complete response letter on September 30, 2020, noting deficiencies related to clinical and
CMC data. Mesoblast continues to be in discussion with the FDA through a well-established regulatory process that may include a
resubmission with a six month review with the aim of achieving approval of remestemcel-L in the treatment of SR-aGVHD in
children.
There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD and only one FDA-approved
treatment in the US for other SR-aGVHD patients.
We believe the U.S. pediatric SR-aGVHD market requires a small, targeted commercial footprint. The target call point for SR-
aGVHD will primarily be board-certified pediatric physicians in hematology/oncology who perform hematopoietic stem cell
transplants. In the U.S., there are approximately 80 centers that perform pediatric transplants, with 50% of all transplants occurring at
approximately 15 centers. Similarly, there are approximately 110 centers that perform adult transplants with half of those transplants
occurring at approximately 20 centers.
The Company has put in place a lifecycle extension strategy to generate evidence-based clinical outcomes to maximize the value
of remestemcel-L in other pediatric and adult rare diseases that do not require large distribution channels. Planning is underway to
conduct a post-marketing study in adult patients with SR-GVHD. In addition, we plan to expand investigator-initiated clinical trials
for chronic GVHD and other indications that are currently underway or planned for the near future.
(1)
This vote includes a change to the original vote by one of the ODAC panel members after electronic voting closed.
Remestemcel-L for Moderate to Severe Acute Respiratory Distress Syndrome due to COVID-19 Infection
Overview
COVID-19 ARDS results from a severe inflammatory reaction, referred to as a cytokine storm, to infection from the SARS
CoV-2 virus. This cytokine storm can cause significant damage to the lungs and other organs and is the primary cause of death in this
high mortality condition. COVID ARDS is a major area of unmet need that typically requires extended hospitalization in intensive
care and intervention by mechanical ventilation.
The extensive safety data of remestemcel-L and its anti-inflammatory effects in acute GVHD is a compelling rationale for
evaluating remestemcel-L in COVID-19 ARDS. Following intravenous delivery of remestemcel-L, the cells migrate to the areas of
inflammation particularly in the lungs resulting in the potential for remestemcel-L to tame the cytokine storm in ARDS.
The clinical protocol evaluating remestemcel-L in patients in the Phase 3 trial was based on results from patients treated with
remestemcel-L under an emergency IND/EAP compassionate use at Mount Sinai Hospital in New York. Twelve patients with
moderate to severe COVID ARDS on mechanical ventilation were given 2 infusions within one week. Nine of the 12 patients (75%)
were successfully taken off the ventilator and discharged from hospital within a median of 10 days.
Nearly 200 million COVID-19 global cases have been confirmed and over 4 million deaths, with 35 million cases and 613,000
deaths occurring in the United States. Currently there is no FDA approved therapy in the United States for the specific treatment of
moderate-to-severe COVID-19 ARDS.
Current Status and Anticipated Milestones
A randomized placebo-controlled Phase 3 trial of remestemcel-L in ventilator-dependent patients with ARDS due to COVID-19
was initiated, with the first patients dosed in May 2020. The trial was halted in December 2020 after the Data Safety Monitoring
Board (DSMB) performed a third interim analysis on the trial’s first 180 patients, noting that the trial was not likely to meet the 30-
day mortality reduction endpoint at the planned 300 patient enrolment. The trial was powered to achieve a primary endpoint of 43%
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reduction in mortality at 30 days for treatment with remestemcel-L on top of maximal care. The DSMB recommended that the trial
complete with the enrolled 222 patients, and that all be followed-up as planned.
The trial enrolled 222 mechanically ventilated COVID-19 patients with moderate/severe ARDS across the US, of whom 217
were randomized 1:1 and received either standard of care alone or standard of care plus 2 intravenous infusions of remestemcel-L at a
dose of 2 million cells/kg 3-5 days apart. This was the same remestemcel-L dosing regimen used in the earlier compassionate use
program where 11 of 12 patients were younger than 65 and 75% successfully came off ventilatory support.
At follow-up through day 60, remestemcel-L reduced overall mortality by 14% across the entire population of treated patients
(n=217), and by 46% in the pre-specified population of patients under age 65 (n=123). In an exploratory analysis through day 60,
remestemcel-L reduced mortality by 75% and increased days alive off mechanical ventilation in patients under age 65 when combined
with dexamethasone, in comparison with controls on dexamethasone.
Mesoblast has met with the FDA in regard to potential emergency use authorization (EUA) for remestemcel-L in the treatment of
ventilator-dependent patients with moderate or severe acute respiratory distress syndrome (ARDS) due to COVID-19. The FDA
advised Mesoblast that an additional clinical study in COVID ARDS would be required which, if statistically positive, could provide a
dataset in conjunction with the recently completed 222 patient clinical study that might be sufficient to support an EUA. FDA provided
guidance that the existing COVID ARDS Investigational New Drug (IND) file and future submissions for remestemcel-L in this
indication may continue to cross-reference manufacturing information in Biologics License Application (BLA) 125706 for pediatric
steroid-refractory acute graft versus host disease (SR-aGVHD). FDA indicated that potency assays must be established and agreed prior
to commencement of the proposed Phase 3 clinical trial. FDA indicated that the potency assays currently in development appeared to be
reasonable based on in vitro results provided in the briefing document, the in vitro activity of the product appears to be relatively well
established, though the relationship between in vitro activity and the product’s actual mechanism of action remains theoretical.
Mesoblast intends to meet with FDA’s Office of Tissue and Advanced Therapies (OTAT) in Q4 CY21 to address potency assays for
remestemcel-L in relation to SR-aGvHD, attributes which we believe to be also relevant to COVID ARDS.
Remestemcel-L for Inflammatory Bowel Disease – Crohn’s Disease and Ulcerative Colitis
Overview
According to recent estimates, more than three million people (1.3%) in the United States alone have inflammatory bowel disease,
with more than 33,000 new cases of Crohn’s disease and 38,000 new cases of ulcerative colitis diagnosed every year. Despite recent
advances, approximately 30% of patients are primarily unresponsive to anti-TNFα agents and even among responders, up to 10% will
lose their response to the drug every year. Up to 80% of patients with medically refractory Crohn’s disease eventually require surgical
treatment of their disease, which can have a devastating impact on quality of life.
Current Status
A randomized, controlled study of remestemcel-L delivered by an endoscope directly to the areas of inflammation and tissue
injury in up to 48 patients with medically refractory Crohn’s disease and ulcerative colitis has commenced at Cleveland Clinic in
October 2020. The investigator-initiated study is the first in humans using local cell delivery in the gut and will enable Mesoblast to
compare clinical outcomes using this delivery method with results from an ongoing randomized, placebo-controlled trial in patients
with biologic-refractory Crohn’s disease where remestemcel-L was administered intravenously.
Rexlemestrocel-L (REVASCOR®) for Advanced and End-stage Heart Failure
Overview
Mesoblast is developing rexlemestrocel-L (REVASCOR) to fill the treatment gap for both advanced and end-stage chronic heart
failure (CHF). The objective is to use rexlemestrocel-L to prevent or delay further progression of heart failure morbidities or cardiac
death in patients who are no longer adequately responsive to maximal standard of care heart failure drugs.
Patients with advanced or end-stage CHF continue to represent high unmet medical need despite recent advances in new
therapeutic agents for chronic heart failure. The American Heart Association estimated in 2017 that prevalence is expected to grow
46% by 2030 in the U.S., affecting more than 8 million Americans. CHF causes severe economic, social, and personal costs. In the
U.S., it is estimated that CHF results in direct costs of $60.2 billion annually when identified as a primary diagnosis and $115.0
billion as part of a disease milieu. Mesoblast believes that targeting high-risk chronic patients with the highest unmet clinical
needs provides the company with the most efficient path to market.
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REVASCOR consists of 150 million MPCs administered by direct cardiac injection in patients suffering from advanced or end-
stage CHF and progressive loss of heart function following damage to the heart muscle caused by a heart attack, coronary artery
disease, hypertension, genetic factors, or other causes.
MPCs release a range of factors when triggered by specific receptor-ligand interactions within damaged tissue. Based on
preclinical data, we believe that the factors released from the MPCs induce functional cardiac recovery by simultaneous activation of
multiple pathways, including induction of endogenous vascular network formation, reduction in harmful inflammation, reduction in
cardiac fibrosis, and reversal of endothelial dysfunction through activation of intrinsic tissue precursors.
CHF is classified in relation to the severity of the symptoms experienced by the patient. The most commonly used classification
system for functional severity of heart failure, established by the NYHA, is:
•
•
•
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Class I (mild): patients experience none or very mild symptoms with ordinary physical activity
Class II (mild/moderate): patients experience fatigue and shortness of breath during moderate physical activity
Class III (moderate/severe): patients experience shortness of breath during even light physical activity
Class IV or end-stage (severe): patients are exhausted even at rest
Risk for recurrent heart failure-related hospitalizations, occurrence of non-fatal myocardial infarction (MI, heart attack) or non-
fatal stroke, or death increases progressively with increases in left ventricular volumes, reduction in left ventricular ejection fraction
(LVEF), and progression in NYHA functional class. Approximately 50% of all CHF patients have heart failure with reduced ejection
fraction (HFrEF) defined as LVEF <40%, and are at considerable risk of repeated hospitalizations and death despite maximal drug
therapy.
Current Status and Anticipated Milestones
Program for Class II/III CHF patients
A multicenter, double-blinded, 1:1 randomized, sham-procedure-controlled Phase 3 study of remestemcel-L was completed
across North America with 565 NYHA Class II/III patients at high risk of repeated heart failure hospitalizations or a terminal cardiac
event (cardiac death, LVAD placement, heart transplant or insertion of an artificial heart). The enrollment criteria for this trial
included a prior decompensated heart failure event (e.g. hospitalization) within the previous nine months and/or very high level of NT-
proBNP, a protein used in diagnosis and screening of CHF. These inclusion criteria were designed for enrichment in patients with
substantial left ventricular contractile abnormality, advanced CHF due to left ventricular systolic dysfunction and higher risk of
recurrent decompensated heart failure hospitalizations and TCEs. This target patient population was shown to respond effectively to
treatment with REVASCOR in our previous Phase 2 trial.
The trial’s primary efficacy endpoint is a comparison of recurrent non-fatal HF-MACE between either MPC-treated patients or
sham-treated controls.
Topline results from the 537 patients who met the criteria which allowed for treatment to occur on a 1:1 randomization basis
between rexlemestrocel-L and sham control were announced in December 2021. Over a mean 30 months of follow-up, patients with
advanced chronic heart failure who received a single endomyocardial treatment with rexlemestrocel-L on top of maximal therapies
had 60% reduction in incidence of heart attacks or strokes and 60% reduction in death from cardiac causes when treated at an earlier
stage in the progressive disease process. Despite significant reduction in the pre-specified endpoint of cardiac death, there was no
reduction in recurrent non-fatal decompensated heart failure events, which was the trial’s primary endpoint.
The combination of the three pre-specified outcomes of cardiac death, heart attack or stroke into a single composite outcome -
called the three-point Major Adverse Cardiovascular Event (MACE) is a well-established endpoint used by the United States Food and
Drug Administration (FDA) to determine cardiovascular risk. Rexlemestrocel-L reduced this three-point MACE by 30% compared to
controls across the population of 537 patients. In the NYHA class II subgroup of 206 patients, rexlemestrocel-L reduced the three-
point MACE by 55% compared to controls.
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Program in End Stage Heart Failure Patients Requiring Mechanical Support
Rexlemestrocel-L is also being evaluated in patients with end-stage HFrEF implanted with a left ventricular assist device
(“LVAD”).
A Phase 2 trial was conducted by a multi-center team of researchers within the United States National Institutes of Health
(“NIH”)-funded Cardiothoracic Surgical Trials Network (“CTSN”), led by Icahn School of Medicine at Mount Sinai, New York. The
National Institute of Neurological Disorders and Stroke, and the Canadian Institutes for Health Research also supported this trial.
Results of this Phase 2 trial were released in November 2018. The trial was a prospective, multi-center, double-blind, placebo
controlled, 2:1 randomized (MPC to placebo), single-dose cohort trial to evaluate the safety and efficacy of injecting a dose of 150
million MPCs into the native myocardium of LVAD recipients. Patients with advanced CHF, implanted with an FDA-approved
LVAD as bridge-to-transplant or destination therapy, were eligible to participate in the trial. All patients were followed until 12
months post randomization.
In this Phase 2 trial, the trial did not show a significant difference in the ability for patients to tolerate a wean for a period of 60
minutes. However, in relation to the clinically meaningful endpoint of reduction in major GI bleeding episodes and related
hospitalizations, a single injection of REVASCOR administered directly into the heart resulted in a 76% reduction in major GI
bleeding events and in a 65% reduction in associated hospitalizations. This suggests that REVASCOR reversed endothelial
dysfunction which is responsible for the abnormal vasculature in the GI tract and severe bleeding in LVAD patients.
Strategic Partnerships
In September 2018, Mesoblast entered into a strategic cardiovascular partnership with Tasly for China. Tasly has met with the
National Medical Products Administration of China to discuss the potential regulatory approval pathway for REVASCOR in China.
Tasly and Mesoblast will leverage each other’s clinical trial results in China, the U.S. and other territories to support their respective
regulatory submissions. In May 2021, Tasly and Mesoblast met with the Center for Drug Evaluation (“CDE”) in China to initiate
formal discussions relating to a study of chronic HFrEF patients.
Rexlemestrocel-L for Chronic Low Back Pain (CLBP) due to Degenerative Disc Disease (DDD)
Overview
MPC-06-ID consists of a unit dose of 6 million MPCs administered by syringe directly into a damaged disc.
In CLBP, damage to the disc is the result of a combination of factors related to aging, genetics, and micro-injuries, which
compromises the disc’s capacity to act as a fluid-filled cushion between vertebrae and to provide anatomical stability. Damage to the
disc also results in an inflammatory response with ingrowth of nerves which results in chronic pain. This combination of anatomic
instability and nerve ingrowth results in CLBP and functional disability.
With respect to mechanisms of action in CLBP, extensive pre-clinical studies have established that MLCs have anti-
inflammatory effects and secrete multiple paracrine factors that stimulate new proteoglycan and collagen synthesis by chondrocytes in
vitro and by resident cells in the nucleus and annulus in vivo.
In 2016, over 7 million people in the U.S. alone were estimated to suffer from CLBP caused by DDD, of which 3.2 million
patients have moderate disease. This market is projected to have annual growth rate similar to that of the US population annual growth
rate. After failure of conservative measures (medication, injections, physical therapy etc.), there is a need for non-opioid treatments
that are effective over a sustained period of time. When disc degeneration has progressed to a point that pain and loss of function can
no longer be managed by conservative means, major invasive surgery such as spinal fusion is the most commonly offered option.
All non-surgical therapies for progressive, severe and debilitating pain due to degenerating intervertebral discs treat the
symptoms of the disease. However, they do not address the underlying cause of the disease. Surgical intervention is not always
successful in addressing the patient’s pain and functional deficit. It has been estimated that the incidence of failed back surgery is as
high as 50% for standard procedures and may increase for more complex surgeries. Total costs of low back pain are estimated to be
between $100.0 billion and $200.0 billion annually with two thirds attributed to patients’ decreased wages and productivity.
As a result, we believe that the most significant unmet need and commercial opportunity in the treatment of CLBP is a therapy
that has the ability to impact the chronic pain and disability associated with the condition.
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Current Status and Anticipated Milestones
The Phase 3 clinical trial for CLBP completed enrollment in March 2018 with 404 patients enrolled across 48 centers in the
United States and Australia randomized 1:1:1 to receive either 6 million MPCs with hyaluronic acid (MPC+HA), 6 million MPCs
without hyaluronic acid (MPC) or saline control. Although the trial's composite outcomes of pain reduction together with functional
responses to treatment were not met by either MPC group; the MPC+HA treatment group achieved substantial and durable reductions
in CLBP compared to control through 24 months across the entire evaluable study population (n=391) compared with saline controls.
Greatest pain reduction was observed in the pre-specified population with CLBP of shorter duration than the study median of 68
months (n=194) and subjects using opioids at baseline (n=168) with the MPC+HA group having substantially greater reduction at all
time points (1, 3, 6, 12, 18 and 24 months) compared with saline controls. There was no appreciable difference in the safety of MPC
groups compared to saline control over the 24-month period of follow-up in the entire study population. In subjects using opioids at
baseline, the MPC+HA demonstrated a reduction in the average opioid dose over 24 months, while saline control subjects
had essentially no change.
Strategic Partnerships
Grünenthal, a global leader in pain management, and Mesoblast entered into a strategic partnership to develop and
commercialize MPC-06-ID for the treatment of chronic low back pain associated with degenerative disc disease in patients who have
exhausted conservative treatment options in Europe and Latin America.
Complementary Technologies
In addition to having the most mature and diverse allogeneic cell therapy product pipeline and technology platform in the field
of cellular medicines, we have strategically targeted the acquisition of rights to technologies that are complementary to and synergistic
with our mesenchymal lineage cell technology platform. The aim of this activity is to maintain our technology leadership position in
the regenerative medicine space, while simultaneously expanding our targeted disease applications and managing the life-cycle of our
current lead programs.
Our complementary technologies and additional product candidates include other types of mesenchymal lineage cells, cell
surface modification technologies, pay-loading technology and protein and gene technologies.
Manufacturing and Supply Chain
Our manufacturing strategy for our cellular product candidates focuses on the following important factors:
(i)
ability for product delineation to protect pricing and partner markets by creating distinct products using discrete
manufacturing processes, culture conditions, formulations, routes of administration, and/or dose regimens;
establishing proprietary commercial scale-up and supply to meet increasing demand;
implementing efficiencies and yield improvement measures to reduce cost-of-goods;
(ii)
(iii)
(iv) maintaining regulatory compliance with best practices; and
(v)
establishing and maintaining multiple manufacturing sites for product supply risk mitigation.
The cell therapy manufacturing and distribution process generally involves five major steps.
•
Procure bone marrow—acquire bone marrow from healthy adults with specific FDA-defined criteria, which is
accompanied by significant laboratory testing to establish the usability of the donated tissues.
•
•
•
•
Create master cell banks—isolate MLCs from the donated bone marrow and perform a preliminary expansion to create
master cell banks. Each individual master cell bank comes from a single donor.
Expand to therapeutic quantities—expand master cell banks to produce therapeutic quantities, a process that can yield
thousands of doses per master cell bank, with the ultimate number depending on the dose for the respective product
candidate being produced.
Formulate, package and cryopreserve.
Distribute—our cellular products are cryopreserved at the manufacturer and shipped to storage sites in the U.S. and other
jurisdictions via cryoshippers. Those distribution centers then re-package and send the products on to treatment centers in
cryoshippers. Treatment centers will either move the products into their own freezers or receive the cryoshipper in “real
time” and the product stays in the cryoshipper until thawed for patient use within a well-defined window. We intend to
continue utilizing this approach in the future.
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To date our product candidates have been manufactured in two-dimensional, or 2D, planar, 10-layer cell factories, using media
containing fetal bovine serum, or FBS.
The relatively small patient numbers and orphan drug designation for remestemcel-L lead us to believe that 2D manufacturing
will be adequate to meet demand for this product candidate if fully approved. We also believe that 2D manufacturing process and
facilities are commercially feasible for Phase 3 trial supply and the initial launch of MPC-06-ID for CLBP.
However, to build up commercial supply for certain of our product candidates long-term, we are developing novel
manufacturing processes using three-dimensional, or 3D, bioreactors with greater capacity to improve efficiency and yields, with
resulting lower-cost of goods. We intend to evaluate products produced in 3D bioreactors in pre-clinical and potentially clinical
studies, which may serve as FDA required comparability studies to 2D if successful.
We are also focusing on the introduction of FBS-free media which has the potential to result in efficiency and yield
improvements to the current 2D process. We intend to conduct comparability studies to illustrate that products produced with this
media are equivalent to those produced using FBS based media. While we remain confident in our ability to deliver successful
outcomes from each of these activities, any unexpected issues or challenges faced in doing so could delay our programs or prevent us
from continuing our programs.
Our manufacturing activities to date have met stringent criteria set by international regulatory agencies, including the FDA. By using
well-characterized cell populations, our manufacturing processes promote reproducibility and batch-to-batch consistency for our
allogeneic cell product candidates. We have developed robust quality assurance procedures and lot release assays to support this
reproducibility and consistency.
Intellectual Property
We have a large patent portfolio of issued and pending claims covering compositions of matter, uses for our mesenchymal
lineage cell-based technologies and other proprietary regenerative product candidates and technologies, as well as for elements of our
manufacturing processes, with approximately 1,089 patents and patent applications across 77 patent families as of July 2021.
One of our major objectives is to continue to protect and expand our extensive estate of patent rights and trade secrets, which we
believe enables us to deliver commercial advantages and long-term protection for our product candidates based on our proprietary
technologies, and support our corporate strategy to target large, mature and emerging healthcare markets for our exploratory
therapeutic product candidates.
More specifically, our patent estate includes issued patent and patent applications in major markets, including, but not limited to,
the United States, Europe, Japan and China. The patents that we have obtained, and continue to apply for, cover mesenchymal lineage
cell technologies and product candidates derived from these technologies, irrespective of the tissue source, including bone marrow,
adipose, placenta, umbilical cord and dental pulp.
These patents cover, among other technology areas, a variety of MLCs (including MPCs and MSCs), and the use of MLC for
expansion of hematopoietic stem cells, or HSCs. Among the indication-specific issued or pending patents covering product candidates
derived from our mesenchymal lineage cells are those which are directed to our lead product candidates: aGVHD, ARDS, CLBP, CHF
and chronic inflammatory conditions such as RA. We also have issued and pending patents covering other pipeline indications,
including diabetic kidney disease, inflammatory bowel disease (e.g., Crohn’s disease), neurologic diseases, eye diseases and additional
orthopedic diseases. In addition, we have in-licensed patents covering complementary technologies, such as other types of
mesenchymal lineage cells, cell surface modification technologies, pay-loading technology and protein and gene technologies, as part
of our strategy to expand our targeted disease applications and manage the life-cycle of our current lead programs.
Our patent portfolio also includes issued and pending coverage of proprietary manufacturing processes that are being used with
our current two-dimensional manufacturing platform as well as the 3D bioreactor manufacturing processes currently under
development. These cell manufacturing patents cover isolation, expansion, purification, scale up, culture conditions, aggregates
minimization, cryopreservation, release testing and potency assays. In addition, we maintain as a trade secret, among other things, our
proprietary FBS-free media used in our 3D bioreactor manufacturing processes.
We maintain trade secrets covering a significant body of know-how and proprietary information relating to our core product
candidates and technologies. We protect our confidential know-how and trade secrets in a number of ways, including requiring all
employees and third parties that have access to our confidential information to sign non-disclosure agreements, limiting access to
confidential information on a need-to-know basis, maintaining our confidential information on secure computers, and providing our
contract manufacturers with certain key ingredients for our manufacturing process.
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In addition, in many major jurisdictions there are other means that may be available to us by which we would be able to extend
the period during which we have commercial exclusivity for our product candidates, which include, but are not limited to the
exclusive right to reference our data, orphan drug exclusivity and patent term extensions.
As part of our strategy, we seek patent protection for our product candidates and technologies in major jurisdictions including
the United States, Europe, Japan, China, and Australia and file independent and/or counterpart patents and patent applications in other
jurisdictions globally that we deem appropriate under the circumstances, including India, Canada, Hong Kong, Israel, Korea and
Singapore. As of July 2021, our patent portfolio includes the following patents and patent applications in the following major
jurisdictions: 81 granted U.S. patents and 37 pending U.S. patent applications; 61 granted Japanese patents and 25 pending Japanese
patent applications; 34 granted Chinese patents and 25 pending Chinese patent applications; 51 granted European patents and 27
pending European patent applications; and 52 granted Australian patents and 22 pending Australian patent applications.
Our policy is to patent the technology, inventions and improvements that we consider important to the development of our
business, only in those cases in which we believe that the costs of obtaining patent protection is justified by the commercial potential
of the technology and associated product candidates, and typically only in those jurisdictions that we believe present significant
commercial opportunities to us. In those cases where we choose neither to seek patent protection nor protect the inventions as trade
secrets, we may publish the inventions so that it defensively becomes prior art in order for us to secure a freedom to operate position
and to prevent third parties from patenting the invention.
We also seek to protect as trade secrets our proprietary and confidential know-how and technologies that are either not
patentable or where we deem it inadvisable to seek patent protection. To this end, we generally require all third parties with whom we
share confidential information and our employees, consultants and advisors to enter into confidentiality agreements prohibiting the
disclosure of confidential information. These agreements with our employees and consultants engaged in the development of our
technologies require disclosure and assignment to us of the ideas, developments, discoveries and inventions, and associated
intellectual property rights, important to our business. Additionally, these confidentiality agreements, among others, require that our
employees, consultants and advisors do not bring to us, or use without proper authorization, any third party’s proprietary technology.
License and Collaboration Agreements
All of our revenue relates to upfront, royalty and milestone payments recognized under the license and collaboration agreements
below. For further information on the categorical revenue breakdown during the last three fiscal years, see “Item 18. Financial
Statements – Note 3”.
Grünenthal arrangement
In September 2019, Mesoblast entered into a strategic partnership with Grünenthal GmbH (Grünenthal) to develop and
commercialize MPC-06-ID, the Company’s Phase 3 allogeneic cell therapy candidate for the treatment of chronic low back pain due
to degenerative disc disease in patients who have exhausted conservative treatment options. The agreement was amended by the
parties in June 2021. Under the partnership, Grünenthal will have exclusive commercialization rights to MPC-06-ID for Europe and
Latin America. Mesoblast may receive up to $112.5 million in upfront and milestone payments prior to product launch, inclusive of
$17.5 million already received, if certain clinical and regulatory milestones are satisfied and reimbursement targets are achieved.
Cumulative milestone payments could exceed $1.0 billion depending on the final outcome of Phase 3 studies and patient adoption.
Mesoblast will also receive tiered double-digit royalties on product sales. There cannot be any assurance as to the total amount of
future milestone and royalty payments that Mesoblast will receive nor when they will be received.
JCR Pharmaceuticals Co., Ltd.—Hematological Malignancies and Hepatocytes Collaboration in Japan
In October 2013, we acquired all of Osiris Therapeutics, Inc.’s business and assets related to culture expanded MSCs. These
assets included assumption of a collaboration agreement with JCR (“JCR Agreement”), which will continue in existence until the later
of 15 years from the first commercial sale of any product covered by the agreement and expiration of the last Osiris patent covering
any such product. JCR is a research and development oriented pharmaceutical company in Japan. Under the JCR Agreement we
assumed from Osiris, JCR has the right to develop our MSCs in two fields for the Japanese market: exclusive in conjunction with the
treatment of hematological malignancies by the use of HSCs derived from peripheral blood, cord blood or bone marrow, or the First
JCR Field; and non-exclusive for developing assays that use liver cells for non-clinical drug screening and evaluation, or the Second
JCR Field. Under the JCR Agreement, JCR obtained rights in Japan to our MSCs, for the treatment of aGVHD. JCR also has a right of
first negotiation to obtain rights to commercialize MSC-based products for additional orphan designations in Japan. We retain all
rights to those products outside of Japan.
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JCR received full approval in September 2015 for its MSC-based product for the treatment of children and adults with aGVHD,
TEMCELL. TEMCELL is the first culture-expanded allogeneic cell therapy product to be approved in Japan. It was launched in Japan
in February 2016.
Under the JCR Agreement, JCR is responsible for all development and manufacturing costs including sales and marketing
expenses. With respect to the First JCR Field, we have received all sales milestone payments, a total of $3.0 million. Ongoing we are
entitled to escalating double-digit royalties in the twenties. These royalties are subject to possible renegotiation downward in the event
of competition from non-infringing products in Japan. With respect to the Second JCR Field, we are entitled to a double digit profit
share in the fifties.
Intellectual property is licensed both ways under the JCR Agreement, with JCR receiving exclusive and non-exclusive rights as
described above from us and granting us non-exclusive, royalty-free rights (excluding in the First JCR Field and Second JCR Field in
Japan) under the intellectual property arising out of JCR’s development or commercialization of MSC-based products licensed in
Japan.
JCR has the right to terminate the JCR Agreement for any reason, and we have a limited right to terminate the JCR Agreement,
including a right to terminate in the event of an uncured material breach by JCR. In the event of a termination of the JCR Agreement
other than for our breach, JCR must provide us with its owned product registrations and technical data related to MSC-based products
licensed in Japan and all licenses of our intellectual property rights will revert to us.
We have expanded our partnership with JCR in Japan for two new indications: for wound healing in patients with EB in October
2018, and for neonatal HIE, a condition suffered by newborns who lack sufficient blood supply and oxygen to the brain, in June 2019.
We will receive royalties on TEMCELL product sales for EB and HIE, if and when such indications receive marketing approval in
Japan.
We have the right to use all safety and efficacy data generated by JCR in Japan to support our development and
commercialization plans for our MSC product candidate remestemcel-L in the United States and other major healthcare markets,
including for GVHD, EB and HIE.
Lonza—Manufacturing Collaboration
In September 2011, we entered into a manufacturing services agreement, or MSA, with Lonza Walkersville, Inc. and Lonza
Bioscience Singapore Pte. Ltd., collectively referred to as Lonza, a global leader in biopharmaceutical manufacturing. Under the
MSA, we pay Lonza on a fee for service basis to provide us with manufacturing process development capabilities for our product
candidates, including formulation development, establishment and maintenance of master cell banks, records preparation, process
validation, manufacturing and other services.
We have agreed to order a certain percentage of our clinical requirements and commercial requirements for MPC products from
Lonza. Lonza has agreed not to manufacture or supply commercially biosimilar versions of any of our product candidates to any third
party, during the term of the MSA, subject to our meeting certain thresholds for sales of our products.
We can trigger a process requiring Lonza to construct a purpose-built manufacturing facility exclusively for our product
candidates. In return if we exercise this option, we will purchase agreed quantities of our product candidates from this facility. We also
have a right to buy out this manufacturing facility at a pre-agreed price two years after the facility receives regulatory approval.
The MSA will expire on the three-year anniversary of the date of the first commercial sale of product supplied under the MSA,
unless it is terminated earlier. We have the option of extending the MSA for an additional 10 years, followed by the option to extend
for successive three-year periods subject to Lonza’s reasonable consent. We may terminate the MSA with two years prior written
notice, and Lonza may terminate with five years prior written notice. The MSA may also terminate for other reasons, including if the
manufacture or development of a product is suspended or abandoned due to the results of clinical trials or guidance from a regulatory
authority. In the event we request that Lonza construct the manufacturing facility described above, neither we nor Lonza may
terminate before the third anniversary of the date the facility receives regulatory approval to manufacture our product candidates,
except in certain limited circumstances. Upon expiration or termination of the MSA, we have the right to require Lonza to transfer
certain technologies and lease the Singapore facility or the portion of such facility where our product candidates are manufactured,
subject to good faith negotiations.
We currently rely, and expect to continue to rely, on Lonza for the manufacture of our product candidates for preclinical and
clinical testing, as well as for commercial manufacture of our product candidates if marketing approval is obtained.
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In October 2019, we entered into an agreement with Lonza for commercial manufacture of remestemcel-L for pediatric SR-
aGVHD. This agreement will facilitate inventory build ahead of the planned US market launch of remestemcel-L and commercial
supply to meet Mesoblast’s long-term market projections. The agreement provides for Lonza to expand its Singapore cGMP facilities
if required to meet long-term growth and capacity needs for the product. Additionally, it anticipates introduction of new technologies
and process improvements which are expected to result in significant increases in yields and efficiencies.
Singapore Economic Development Board (EDB)—Singapore Operations
In May 2014, the Economic Development Board of Singapore, or EDB, granted us certain financial incentives tied to revenues
generated by our Singapore operations, among other things. These incentives include two separate 15-year periods (each broken into
five-year increments) of potential incentives, one related primarily to non-manufacturing activities and the other related to
manufacturing activities. We will be eligible for these incentives if we meet certain investment or activity thresholds in Singapore,
including employment levels, amounts of business or manufacturing related expenses, and the performance of various services
including business development, planning, manufacturing, intellectual property management, marketing and distribution.
For example, in order to obtain full financial benefits from the EDB for our manufacturing-related incentives, we must
manufacture at least 50% of the global volume of our first three commercial products in Singapore (subject to certain exceptions), and
we would be required to construct and operate a manufacturing facility in Singapore, and hire and maintain a specified number of
professionals (including supply chain personnel) in connection with the operation of that facility. The activities under our MSA with
Lonza could be used to fulfill all or part of the requirements to obtain the EDB financial incentives.
Central Adelaide Local Health Network Incorporated—Mesenchymal Precursor Cell Intellectual Property
In October 2004, we, through our wholly-owned subsidiary, Angioblast Systems Inc., now Mesoblast, Inc., acquired certain
intellectual property relating to our MPCs, or Medvet IP, pursuant to an Intellectual Property Assignment Deed, or IP Deed, with
Medvet Science Pty Ltd, or Medvet. Medvet’s rights under the IP Deed were transferred to Central Adelaide Local Health Network
Incorporated, or CALHNI, in November 2011. In connection with our use of the Medvet IP, we are obligated to pay CALHNI, as
successor in interest to Medvet, (i) certain aggregated milestone payments of up to $2.2 million and single-digit royalties on net sales
of products covered by the Medvet IP, for cardiac muscle and blood vessel applications and bone and cartilage regeneration and repair
applications, subject to minimum annual royalties beginning in the first year of commercial sale of those products and (ii) and single-
digit royalties on net sales of the specified products for applications outside the specified fields. Additionally, we are obligated to pay
CALHNI a double-digit percentage in the teens of any revenue that we receive in exchange for a grant of a sublicense to the Medvet
IP in the specified fields. Under the IP Deed, we also granted to Medvet a non-exclusive, royalty-free license to the Medvet IP for
non-commercial, internal research and academic research.
Pursuant to the IP Deed, we were assigned the rights in three U.S. patents or patent applications (including all substitutions,
continuations, continuations-in-part, divisional, supplementary protection certificates, renewals, all letters patent granted thereon, and
all reissues, reexaminations, extensions, confirmations, revalidations, registrations and patents of addition and foreign equivalents
thereof) and all future intellectual property rights, including improvements, that might arise from research conducted at CALHNI
related to MPCs and methods of isolating, culturing and expanding MPCs and their use in any therapeutic area. We also acquired all
related materials, information and know-how.
Osiris Acquisition—Continuing Obligations
In October 2013, we and Osiris entered into a purchase agreement, as amended, or the Osiris Purchase Agreement, under which
we acquired all of Osiris’ business and assets related to culture expanded MSCs. Pursuant to the Osiris Purchase Agreement, we also
agreed to make certain milestone and royalty payments to Osiris pertaining to remestemcel-L for the treatment of aGVHD and
Crohn’s disease. Each milestone payment is for a fixed dollar amount and may be paid in cash or our ordinary shares or ADSs, at our
option. The maximum amount of future milestone payments we may be required to make to Osiris is $40.0 million. Any ordinary
shares or ADSs we issue as consideration for a milestone payment will be subject to a contractual one year holding period, which may
be waived in our discretion. In the event that the price of our ordinary shares or ADSs decreases between the issue date and the
expiration of any applicable holding period, we will be required to make an additional payment to Osiris equal to the reduction in the
share price multiplied by the amount of issued shares under that milestone payment. This additional payment can be made either
wholly in cash or 50% in cash and 50% in our ordinary shares, in our discretion. We have also agreed to pay varying earnout amounts
as a percentage of annual net sales of acquired products, ranging from low single-digit to 10% of annual sales in excess of $750.0
million. These royalty payments will cease after the earlier of a ten year commercial sales period and the first sale of a relevant
competing product. The first royalty payments were made in 2016.
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Tasly Pharmaceutical Group — Cardiovascular Alliance for China
In July 2018, we entered into a Development and Commercialization Agreement with Tasly.
The Development and Commercialization Agreement provides Tasly with exclusive rights to develop, manufacture and
commercialize REVASCOR in China for the treatment or prevention of CHF and MPC-25-IC for the treatment or prevention of AMI.
Tasly will fund all development, manufacturing and commercialization activities in China for REVASCOR and MPC-25-IC. On
closing, we received a $20.0 million upfront technology access fee. Further, we will receive $25.0 million upon product regulatory
approvals in China. Mesoblast will receive double-digit escalating royalties on net product sales. Mesoblast is eligible to receive six
escalating milestone payments upon the product candidates reaching certain sales thresholds in China.
Tasly can terminate the Development and Commercialization Agreement with a specified amount of notice, on the later of (a)
third anniversary of the agreement coming into effect and (b) receipt of marketing approval in China for each of REVASCOR or
MPC-25-IC. Mesoblast has termination rights with respect to certain patent challenges by Tasly and if certain competing activities are
undertaken by Tasly. Either party may terminate the agreement on material breach of the agreement if such breach is not cured within
the specified cure period or if certain events related to bankruptcy of the other party occur.
TiGenix NV – patent license for treatment of fistulae
In December 2017, we entered into a Patent License Agreement with TiGenix, now a wholly owned subsidiary of Takeda,
which granted Takeda exclusive access to certain of our patents to support global commercialization of the adipose-derived MSC
product Alofisel®, previously known as Cx601, a product candidate of Takeda, for the local treatment of fistulae. The agreement
includes the right for Takeda to grant sub-licenses to affiliates and third parties.
As part of the agreement, we received $5.9 million (€5.0 million) before withholding tax as a non-refundable upfront payment
and a further payment of $5.9 million (€5.0 million) before withholding tax 12 months after the patent license agreement date. We are
entitled to further payments of up to €10.0 million when Takeda reaches certain product regulatory milestones. Additionally, we
receive single digit royalties on net sales of Alofisel®.
The agreement will continue in full force in each country (other than the United States) until the date upon which the last issued
claim of any licensed patent covering Alofisel® expires in such country (currently expected to be 2029) or, with respect to the United
States, until the later of (i) the date upon which the last issued claim of any licensed patent covering Alofisel® in the United States
expires (currently expected to be around 2031) or (ii) the expiration of the regulatory exclusivity period in the United States with an
agreed maximum term.
Either we or Takeda may terminate the agreement for any material breach that is not cured within 90 days after notice thereof.
We also have the right to terminate the agreement, with a written notice in the event that Takeda file a petition in bankruptcy or
insolvency or Takeda makes an assignment of substantially all of its assets for the benefit of its creditors.
Takeda have the right to terminate their obligation to pay royalties for net sales in a specific country if it is of the opinion that
there is no issued claim of any licensed patent covering Alofisel® in such country, subject to referral of the matter to the joint
oversight/cooperation committee established under the agreement if we disagree.
Competition
The biotechnology and pharmaceutical industries are highly competitive and are characterized by rapidly advancing
technologies and a strong emphasis on proprietary products. Any product candidates that we and our collaborators successfully
develop and commercialize will compete with existing products and new products that may become available in the future.
A number of our potential competitors, particularly large biopharmaceutical companies, have significantly greater financial
resources and general expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining
regulatory approvals and marketing approved products than we do. Our market has been characterized by significant consolidation by
pharmaceutical and biotechnology companies, which is likely to result in even more resources being concentrated among a smaller
number of our potential competitors.
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Government Regulation
We are developing cellular therapy product candidates. These products are subject to extensive legislation. Governmental
authorities around the world, including the FDA, are charged with the administration and enforcement of numerous laws and
regulations that impact all aspects of the development, production, importing, testing, approval, labeling, promotion, advertising, and
sale of products such as ours. Such governmental authorities are also charged with administering what is often a lengthy and technical
review and approval process before candidate therapies such as ours may be marketed for any use. Authorization or approval for
marketing must generally be obtained from the local health authorities in each country in which the product is to be sold. Approval
and authorization procedures may differ from country to country, as may the requirements for maintaining approvals. It is typical
however for these procedures to require evidence of rigorous testing and documentation regarding the candidate therapy, which may
include significant non-clinical and clinical evaluations. Extensive controls and requirements apply to the non-clinical and clinical
development of our therapeutic candidates. Those requirements and their enforcement and implementation by local regulatory
authorities around the world significantly impact whether a product candidate can be developed into a marketable product, and notably
impact the cost, resources and timing for any such development. Changes in regulatory requirements and differences in requirements
from country to country may also increase the costs of bringing new technologies such as ours to market and maintaining approvals, if
obtained.
To obtain marketing approval of a new product, an extensive dossier of evidence establishing the safety, efficacy and quality of
the product must be submitted for review by regulatory authorities. Dossier form and substance, while often similar may have notable
differences in different countries. Submission of an application to regulators does not guarantee approval to market that product,
despite the fact that criteria for approval in many countries may be quite similar. Some regulatory authorities may require additional
data and analyses, and may have standards that apply that are more stringent than others for review of the submitted dossier and
content. Additionally, the review process, risk tolerance, and openness to new technologies may vary from country to country.
Obtaining marketing approval can take several months to several years, depending on the country, the quality of the data, the
efficiencies and procedures of the reviewing regulatory authority and their familiarity with the product technology. Some countries,
like the US, may have accelerated approval processes for certain categories of products, for example products which represent a
breakthrough in the field, or which meet certain thresholds and have obtained certain designations of particular interest. Nevertheless,
ultimate availability to patients may be affected, even post approval, by requirements in some countries to negotiate selling prices and
reimbursement terms with government regulators or other payors.
Maintaining marketing approval may require the conduct of additional post-approval studies in some situations, and the
continued capture, monitoring and assessment of safety and other information about the product, as well as adherence to requirements
to ensure the purity and integrity of manufactured product. The process for obtaining and maintaining regulatory authorizations and
approvals to market our products and the subsequent compliance with appropriate federal, state, local and foreign laws and regulations
require the expenditure of substantial time and the commitment of significant financial and other resources, and we may not be able to
obtain the required regulatory approvals.
Product Development Process
All of our product candidates are regulated as biological products by the Center for Biologics Evaluation and Research in the
FDA. In the United States, biological products are subject to federal regulation under the Federal Food, Drug, and Cosmetic Act
(“FDCA”), the Public Health Service (“PHS”) Act, and other federal, state, local and foreign statutes and regulations. Both the FDCA
and the PHS Act, as applicable, and their corresponding regulations govern, among other things, the testing, manufacturing, safety,
efficacy, labeling, packaging, storage, record keeping, distribution, import, export, reporting, advertising and other promotional
practices involving drugs and biological products. Before clinical testing of a new drug or biological product may commence, the
sponsor of the clinical study must submit an application for investigational new drug (“IND”) application to FDA, which must
include, among other information, the proposed clinical study protocol(s). To obtain marketing authorization once clinical testing has
concluded, a BLA must be submitted for FDA approval.
The process required by the FDA before a biological product may be marketed in the U.S. generally involves the following:
•
•
completion of nonclinical laboratory studies, meaning in vivo and in vitro experiments in which an investigational product
is studied prospectively in a test system under laboratory conditions to determine its safety, must be conducted according
to cGLP (good laboratory practice) regulations, as well as, in the case of nonclinical laboratory studies involving animal
test systems, in accordance with applicable requirements for the humane use of laboratory animals and other applicable
regulations;
submission to the FDA of an application for an IND, which must become effective before human clinical studies may
begin;
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•
•
•
•
•
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performance of adequate and well-controlled human clinical studies according to the FDA’s cGCPs (good clinical
practices) and all other applicable regulatory requirements for the protection of human research subjects and their health
information, to establish the safety, purity and potency of the proposed product for its intended use and to ensure the
product has an appropriate risk-benefit profile;
development and demonstration of a manufacturing process that can produce product of consistent and adequate quality;
submission to the FDA of a BLA for marketing approval demonstrating the quality, safety, and efficacy of the product
which must be supported by substantial evidence from adequate and well-controlled clinical investigations as well as
demonstration of mode of action through non-clinical studies, evidence to support appropriate manufacturing capabilities
and controls, and evidence of the stability of the product in the form it is intended to be provided;
negotiation with FDA of proposed product labeling (and determination of appropriate risk mitigation strategies and
programs, if any required), as well as participation in any required advisory committee proceedings;
satisfactory completion of an FDA inspection of all manufacturing, testing and distribution facilities where the product is
produced, tested or stored and distributed, to assess compliance with cGMP (good manufacturing practices) to assure that
the facilities, methods and controls for production are adequate to preserve the product’s identity, strength, purity and
potency;
potential FDA inspection of nonclinical facilities and likely inspection of select clinical study sites that generated the data
in support of the BLA; and
FDA review and approval of the BLA.
Human testing of a biological product candidate is preceded by preclinical testing, including nonclinical laboratory studies in
which the product candidate is studied prospectively in a test system under laboratory conditions to determine its safety. A test system
may include any animal, plant, microorganism, or subparts thereof to which the test or control article is administered or added for
study.
The clinical study sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical
data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND. Some preclinical testing
may continue even after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the
FDA places the clinical study covered by the IND on a clinical hold within that 30-day time period. In such a case, the IND sponsor
and the FDA must resolve any outstanding concerns before the clinical study can begin. The FDA may also impose clinical holds on a
product candidate at any time during clinical studies due to safety concerns or non-compliance. If the FDA imposes a clinical hold,
studies may not recommence unless FDA removes the clinical hold and then only under terms authorized by the FDA. Accordingly,
we cannot be sure that submission of an IND will result in the FDA allowing clinical studies to begin, or that, once begun, issues will
not arise that suspend or terminate such studies.
Clinical studies involve the administration of the product candidate to subjects under the supervision of qualified independent
investigators, generally physicians or other qualified scientists and medical personnel who are not employed by or under the study
sponsor’s control. Clinical studies are conducted under protocols detailing, among other things, the objectives of the clinical study,
dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety, including stopping
rules that assure a clinical study will be stopped if certain adverse events, or AEs, should occur. Each new protocol and certain
amendments to the protocol must be submitted to the FDA. Clinical studies must be conducted in accordance with the FDA’s cGCP
regulations and guidance, and monitored to ensure compliance with applicable regulatory requirements. These include the requirement
that written informed consent is obtained from all subjects who participate in the study. Further, each clinical study must be reviewed
and approved by an independent Institutional Review Board, or IRB, at or servicing each institution at which the clinical study will be
conducted. An IRB is charged with protecting the welfare and rights of study participants and considers such items as whether the
risks to individuals participating in the clinical studies are minimized and are reasonable in relation to anticipated benefits. The IRB
also approves the form and content of the informed consent document that must be signed by each clinical study subject or his or her
legal representative and must monitor the clinical study until completed. Throughout the study, certain information about certain
serious adverse events must be reported to the IRB, in some cases on an expedited basis, and to FDA (as well as to regulators in other
countries in which studies of the product are also being conducted).
Human clinical studies are typically conducted in three sequential phases that may in some cases overlap or be combined:
•
Phase 1. The product candidate is initially introduced into a small number of human subjects. In the case of cellular
therapy products, the initial human testing is conducted in patients with the disease or condition targeted by the biological
product candidate. Phase 1 studies are intended to determine the metabolism and pharmacologic actions (including
adverse reactions), the side effects associated with increasing doses, immunogenicity, and, if possible, to gain early
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evidence of effectiveness. The information obtained in Phase 1 should be sufficient to permit the design of well-
controlled, scientifically valid Phase 2 studies.
•
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Phase 2. Controlled clinical studies are conducted in a larger number of human subjects to evaluate the effectiveness of
the drug for a particular indication or indications in patients with the disease or condition under study. Phase 2 studies are
intended to assess side effects and risks, and to examine exposure–response relationships, and to further explore
pharmacologic actions and immunogenicity associated with the drug. These studies also provide helpful information for
the design of phase 3 studies.
Phase 3. Assuming preliminary evidence suggesting effectiveness has been obtained in phase 2 (generally considered to
be “proof of concept”), controlled studies are conducted in a larger group of subjects to gather additional information
about effectiveness and safety in order to evaluate the overall benefit-risk relationship of the drug and to provide an
adequate basis for physician labeling.
Post-approval clinical studies, sometimes referred to as Phase 4 clinical studies, may be conducted after initial marketing
approval. In some cases, FDA may require a Phase 4 study to be performed as a condition of product approval. Sponsors also can
voluntarily conduct Phase 4 studies to gain additional experience from the treatment of patients in the intended therapeutic indication,
particularly for long-term safety follow-up or in select populations. FDA regulations extend to all phases of clinical development and
apply to sponsors and investigators of clinical studies. FDA oversight includes inspection of the sites and investigators involved in
conducting the studies.
Concurrent with clinical studies, companies usually complete additional animal studies, and must also develop additional
information about the physical characteristics of the biological product as well as finalize a process for manufacturing the product in
commercial quantities in accordance with cGMP requirements.
To help reduce the risk of the introduction of adventitious agents with use of biological products, the PHS Act emphasizes the
importance of manufacturing control for products whose attributes cannot be precisely defined. The manufacturing process must be
capable of consistently producing quality batches of the product candidate and, among other things; the sponsor must develop methods
for testing the identity, purity and potency of the final biological product. All such testing and controls requires the application of
significant human and financial resources.
Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the
biological product candidate does not undergo unacceptable deterioration over its shelf life.
U.S. Review and Approval Processes
After the completion of clinical studies of a product candidate, FDA approval of a BLA must be obtained before commercial
marketing of the biological product. The BLA must include results of product development, laboratory and animal studies, human
studies, information on the manufacture and composition of the product, proposed labeling and other relevant information. In addition,
under the Pediatric Research Equity Act (“PREA”), a BLA or supplement to a BLA must contain data to assess the safety and
effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and
administration for each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for
submission of data or full or partial waivers. Unless otherwise required by regulation, PREA does not apply to any biological product
for an indication for which orphan designation has been granted. The testing and approval processes require substantial time and effort
and there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a
timely basis, if at all.
Under the Prescription Drug User Fee Act (“PDUFA”), as amended, each BLA must be accompanied by a substantial user fee.
PDUFA also imposes an annual product fee for biologics and an annual establishment fee on facilities used to manufacture
prescription biologics. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for
the first application filed by a small business.
Additionally, an application fee is not assessed on BLAs for products designated as orphan drugs, unless the product also
includes a non-orphan indication.
Within 60 days following submission of the application, the FDA reviews the BLA submitted to determine if it is substantially
complete before the agency accepts it for filing. The FDA may refuse to file any marketing application that it deems incomplete or not
properly reviewable at the time of submission and may request additional information. In this event, the BLA must be resubmitted
with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Once the
submission is accepted for filing, the FDA begins an in-depth substantive review of the BLA. The FDA reviews the application to
determine, among other things, whether the proposed product is safe and effective, for its intended use, and has an acceptable purity
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profile, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, safety,
potency and purity. The FDA may refer applications for novel products or products that present difficult questions of safety or
efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a
recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the
recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. During the
product approval process, the FDA also will determine whether a Risk Evaluation and Mitigation Strategy, or REMS, is necessary to
assure the safe use of the product. If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS;
the FDA will not approve the application without a REMS, if required.
Before approving a BLA, the FDA will typically inspect the facilities at which the product is manufactured. The FDA will not
approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements
and adequate to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the
FDA will typically inspect one or more clinical sites to assure that the clinical studies were conducted in compliance with IND study
and cGCP requirements. To assure cGMP and cGCP compliance, an applicant must incur significant expenditure of time, money and
effort in the areas of training, record keeping, production, and quality control.
Notwithstanding the submission of relevant data and information, the FDA may ultimately decide that the BLA does not satisfy
its regulatory criteria for approval and deny approval. Data obtained from clinical studies are not always conclusive and the FDA may
interpret data differently than we interpret the same data. If the agency decides not to approve the marketing application, it will issue a
complete response letter describing specific deficiencies in the application identified by the FDA. Additionally, the complete response
letter may recommend actions that the applicant might take to place the application in a condition for approval. Such recommended
actions could include the conduct of additional studies. If a complete response letter is issued, the applicant may either resubmit the
BLA, addressing all of the deficiencies identified in the letter, or withdraw the application.
If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the
indications for use may otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require
that certain contraindications, warnings or precautions be included in the product labeling. The FDA may impose restrictions and
conditions on product distribution, prescribing, or dispensing in the form of a risk management plan, or otherwise limit the scope of
any approval. In addition, the FDA may require post-approval clinical studies, to further assess a product’s safety and effectiveness,
and testing and surveillance programs to monitor the safety of approved products that have been commercialized.
One of the performance goals agreed to by the FDA under the PDUFA is to complete its review of 90% of standard BLAs
within 10 months from filing and 90% of priority BLAs within six months from filing, whereupon a review decision is to be made.
The FDA does not always meet its PDUFA goal dates and its review goals are subject to change from time to time. The review
process and the PDUFA goal date may be extended by three months if the FDA requests or the application sponsor otherwise provides
additional information or clarification regarding information already provided in the submission within the last three months before
the PDUFA goal date.
Post-Approval Requirements
Maintaining substantial compliance with applicable federal, state, and local statutes and regulations requires the expenditure of
substantial time and the commitment of substantial human and financial resources. Rigorous and extensive FDA regulation of
biological products continues after approval, particularly with respect to cGMP. We will rely, and expect to continue to rely, on third
parties for the production of clinical and commercial quantities of any products that we may commercialize. Manufacturers of our
products are required to comply with applicable requirements in the cGMP regulations, including quality control and quality assurance
and maintenance of records and documentation.
Other post-approval requirements applicable to drug and biological products include reporting post marketing surveillance to
continuously monitor the safety of the approved product. This is done through the collection of spontaneous reports of adverse events
and side effects, the assessment of safety signals, if any, and prescription event monitoring, among other methods. FDA maintains a
system of postmarketing surveillance because all possible side effects of a new drug may not be evident in preapproval studies, which
involve only several hundred to several thousand patients. Through postmarketing surveillance and risk assessment programs, FDA
and sponsors seek to identify adverse events that did not appear during the drug approval process. In addition, FDA monitors adverse
events such as adverse reactions and poisonings. FDA may use this information for a variety of purposes to identify safety signals not
previously identified with the product, to update drug labeling, and, on rare occasions, to reevaluate the approval or marketing
decision with respect to a product.
In addition, post-approval regulatory requirements include reporting of cGMP deviations that may affect the identity, potency,
purity and overall safety of a distributed product, record-keeping requirements, and complying with electronic record and signature
requirements. After a BLA is approved, the product also may be subject to official lot release. As part of the manufacturing process,
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the manufacturer is required to perform certain tests on each lot of the product before it is released for distribution. If the product is
subject to official release by the FDA, the manufacturer submits samples of each lot of product to the FDA together with a release
protocol showing a summary of the history of manufacture of the lot and the results of all of the manufacturer’s tests performed on the
lot. The FDA also may perform certain confirmatory tests on lots of some products before releasing the lots for distribution by the
manufacturer. In addition, the FDA conducts laboratory research related to the regulatory standards on the safety, purity, potency, and
effectiveness of drug and biological products. The FDA will also conduct routine scheduled and unannounced inspections of drug
production and control facilities and processes, using field investigators and analysts, to assure ongoing safety and effectiveness of
approved marketed products. Inspections may be made in conjunction with regulators from other jurisdictions and in certain cases,
inspection findings and observations may be made public or may impair our ability to use the inspected facility, or to continue to
produce and market a product.
We also must comply with the FDA’s advertising and promotion requirements, such as those related to direct- to-consumer
advertising, the prohibition on promoting products for uses or in patient populations that are not described in the product’s approved
labeling (known as “off-label use”), industry-sponsored scientific and educational activities, and promotional activities involving the
internet and notably, social media. In addition, discovery of previously unknown problems or the failure to comply with the applicable
regulatory requirements may result in restrictions on the marketing of a product or withdrawal of the product from the market as well
as possible civil or criminal sanctions. Failure to comply with the applicable U.S. requirements at any time during the product
development process, approval process or after approval, may subject an applicant or manufacturer to administrative or judicial civil
or criminal sanctions and adverse publicity. Sanctions authorized under FDA’s legal authorities could include refusal to approve
pending applications, withdrawal of an approval, clinical hold, warning or untitled letters, product recalls, product seizures, total or
partial suspension of production or distribution, injunctions, fines, mandated corrective advertising or communications with doctors,
debarment, restitution, disgorgement of profits, or civil or criminal penalties.
Violations of the FDCA may serve as a basis for the refusal of, or exclusion from, government contracts, including federal
reimbursement programs, as well as other adverse consequences including lawsuits and actions by state attorneys general. Any agency
or judicial enforcement action could have a material adverse effect on us. Drug and biological product manufacturers and other entities
involved in the manufacture and distribution of approved drug or biological products are required to register their establishments with
the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for
compliance with cGMPs and other laws. Accordingly, manufacturers must continue to expend time, money, and effort in the area of
production and quality control to maintain cGMP compliance. Discovery of problems with a product after approval may result in
restrictions on a product, manufacturer, or holder of an approved BLA, including withdrawal of the product from the market. In
addition, changes to a manufacturing process or facility generally require prior FDA approval before being implemented and other
types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further
FDA review and approval.
U.S. Patent Term Restoration and Marketing Exclusivity
Depending upon the timing, duration and specifics of the FDA approval of the use of our product candidates, some of our U.S.
patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984,
commonly referred to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to
five years as compensation for patent term lost during product development and the FDA regulatory review process. However, patent
term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent
term restoration period is generally one-half the time between the effective date of an IND and the submission date of a new drug
application, or NDA, or BLA plus the time between the submission date of an NDA or BLA and the approval of that application. Only
one patent applicable to an approved product is eligible for the extension and the application for the extension must be submitted prior
to the expiration of the patent. The U.S. Patent and Trademark Office, in consultation with the FDA, reviews and approves the
application for any patent term extension or restoration.
Under the Hatch-Waxman Amendments, a drug product containing a new chemical entity as its active ingredient is entitled to
five years of market exclusivity, and a product for which the sponsor is required to generate new clinical data is entitled to three years
of market exclusivity. A drug or biological product can also obtain pediatric market exclusivity in the U.S. Pediatric exclusivity, if
granted, adds six months to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of other
exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric study in accordance with an
FDA-issued “Written Request” for such a study.
The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway for biological products
shown to be similar to, or interchangeable with, an FDA-licensed reference biological product. Biosimilarity, which requires that there
be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and
potency, can be shown through analytical studies, animal studies, and a clinical study or studies. Interchangeability requires that a
product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical
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results as the reference product and, for products administered multiple times, the biologic and the reference biologic may be switched
after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of
the reference biologic.
A new biologic is granted 12 years of exclusivity from the time of first licensure during which a biosimilar may not be launched.
Government Regulation Outside of the U.S.
European Union Regulation
In addition to regulations in the U.S., we will be subject to a variety of regulations in other jurisdictions governing, among other
things, clinical studies and any commercial sales and distribution of our products. In particular, we view the EU and Japan as
important jurisdictions for our business.
For purposes of developing our products, we must obtain the requisite approvals from regulatory authorities in each country
prior to the commencement of clinical studies or marketing of the product in those countries. Certain countries outside of the U.S.
have a similar process that requires the submission of a clinical study application much like the IND prior to the commencement of
human clinical studies. In the EU, for example, a clinical trial application (“CTA”), must be submitted to each country’s national
health authority and an independent ethics committee, much like the FDA and the IRB, respectively. Once the CTA is approved in
accordance with a country’s requirements, clinical study development may proceed.
The EU has two main procedures for obtaining marketing authorizations in the EU Member States: a centralized procedure or
national authorization procedure, under the latter of which one can seek to go through the mutual recognition procedure or the
decentralized procedure. All biotechnology products are assessed through the centralized procedure.
Under the centralized authorization procedure, sponsors submit a single marketing-authorization application to the EMA. This
allows the marketing-authorization holder to market the product and make it available to patients and healthcare professionals
throughout the EU on the basis of a single marketing authorization. EMA's Committee for Medicinal products for Human Use
(“CHMP”) carries out a scientific assessment of the application and give a recommendation on whether the medicine should be
marketed or not. Once granted by the EMA, the centralized marketing authorization is valid in all EU Member States as well as in the
European Economic Area countries Iceland, Liechtenstein and Norway. The centralized procedure is mandatory for biotechnology
products.
Any product candidates we seek to commercialize in the EU are subject to review and approval by the European Medicines
Authority (“EMA”). Submissions for marketing authorization to the EMA must be received and validated by that body which appoints
a Rapporteur and Co-Rapporteur to review it. The entire review process must be completed within 210 days, with a “clock-stop” at
day 120 to allow the submitting company to respond to questions set forth in the Rapporteur and Co-Rapporteur’s assessment report.
Once the company responds in full, the clock for review re-starts on day 121. If further clarification is needed, the EMA may request
an Oral Explanation on day 180, and the company submitting the application must appear before the CHMP to provide the requested
information. On day 210, the CHMP will vote to recommend for or against the approval of the application. The final decision of EMA
for marketing authorization following a positive CHMP recommendation is typically made within 60 days, with a draft decision
within 15 days of the CHMP recommendation.
After Marketing Authorizations have been granted, the company must submit periodic safety reports to the EMA (if approval
was granted under the Centralized Procedure) or to the National Health Authorities (if approval was granted under the DCP or the
MRP). In addition, pharmacovigilance measures must be implemented and monitored to ensure appropriate adverse event collection,
evaluation and expedited reporting, as well as timely updates to any applicable risk management plans. For some medications, post
approval studies may be required to complement available data with additional data to evaluate long term effects or to gather
additional efficacy data.
European marketing authorizations have an initial duration of five years. After this time, the marketing authorization may be
renewed by the competent authority on the basis of re-evaluation of the risk/benefit balance. Any marketing authorization which is not
followed within three years of its granting by the actual placing on the market of the corresponding medicinal product ceases to be
valid.
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EU Exclusivity Periods
To obtain regulatory approval of an investigational biological product under EU regulatory systems, we must submit a
marketing authorization application. The application used to file the BLA in the U.S. is similar to that required in the EU, with the
exception of, among other things, country-specific document requirements. The EU also provides opportunities for market exclusivity.
For example, in the EU, upon receiving marketing authorization, new chemical entities generally receive eight years of data
exclusivity and an additional two years of market exclusivity. If granted, data exclusivity prevents regulatory authorities in the EU
from referencing the innovator’s data to assess a generic application. During the additional two-year period of market exclusivity, a
generic marketing authorization can be submitted, and the innovator’s data may be referenced, but no generic product can be marketed
until the expiration of the market exclusivity. However, there is no guarantee that a product will be considered by the EU’s regulatory
authorities to be a new chemical entity, and products may not qualify for data exclusivity. Products receiving orphan designation in the
EU can receive 10 years of market exclusivity, during which time no similar medicinal product for the same indication may be placed
on the market. An orphan product can also obtain an additional two years of market exclusivity in the EU for pediatric studies. No
extension to any supplementary protection certificate can be granted on the basis of pediatric studies for orphan indications.
The criteria for designating an “orphan medicinal product” in the EU are similar in principle to those in the U.S. Under Article 3
of Regulation (EC) 141/2000, a medicinal product may be designated as orphan if (1) it is intended for the diagnosis, prevention or
treatment of a life-threatening or chronically debilitating condition; (2) either (a) such condition affects no more than five in 10,000
persons in the EU when the application is made, or (b) the product, without the benefits derived from orphan status, would not
generate sufficient return in the EU to justify investment; and (3) there exists no satisfactory method of diagnosis, prevention or
treatment of such condition authorized for marketing in the EU, or if such a method exists, the product will be of significant benefit to
those affected by the condition, as defined in Regulation (EC) 847/2000. Orphan medicinal products are eligible for financial
incentives such as reduction of fees or fee waivers and are, upon grant of a marketing authorization, entitled to 10 years of market
exclusivity for the approved therapeutic indication. The application for orphan drug designation must be submitted before the
application for marketing authorization. The applicant will receive a fee reduction for the marketing authorization application if the
orphan drug designation has been granted, but not if the designation is still pending at the time the marketing authorization is
submitted. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval
process.
The 10-year market exclusivity may be reduced to six years if, at the end of the fifth year, it is established that the product no
longer meets the criteria for orphan designation, for example, if the product is sufficiently profitable not to justify maintenance of
market exclusivity. Additionally, marketing authorization may be granted to a similar product for the same indication at any time if:
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the second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically
superior;
the applicant consents to a second orphan medicinal product application; or
the applicant cannot supply enough orphan medicinal product.
In addition to law and regulation specific to drug development, we note that new data protection regulations that have gone into
effect in Europe are likely to have a significant impact on our activities, personnel, and may have an impact on our ability to timely
complete clinical trials and effectively develop and commercialize our product candidates. The General Data Protection Regulation
(the “GDPR”) was approved and adopted by the EU Parliament in April 2016 and went into effect on May 25, 2018. Unlike
a Directive, the GDPR does not require any enabling legislation to be passed by any government. The GDPR not only applies to
organizations located within the EU but may also apply to organizations located outside of the EU if they offer goods or services to, or
monitor the behavior of, EU data subjects or if they process the personal data of subjects residing in the European Union. The
implications of this regulation are therefore far reaching and may impose significant burdens on the Company and its processes and
systems. Additionally, the UK government has implemented a Data Protection Bill, which also went into effect on May 25, 2018, that
substantially implements the GDPR. For other countries outside of the EU, such as countries in Eastern Europe, Latin America or
Asia, the requirements governing the conduct of clinical studies, product licensing, coverage, pricing and reimbursement vary from
country to country. In all cases, again, the clinical studies are conducted in accordance with cGCP and the applicable regulatory
requirements and the ethical principles that have their origin in the Declaration of Helsinki.
If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines,
suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
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Pharmaceutical Coverage, Pricing and Reimbursement
Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we obtain
regulatory approval. In the U.S. and markets in other countries, sales of any products for which we receive regulatory approval for
commercial sale will depend, in part, on the availability of coverage and adequate reimbursement from third-party payors. Third-party
payors include government programs such as Medicare or Medicaid, managed care plans, private health insurers, and other
organizations. These third-party payors may deny coverage or reimbursement for a product or therapy in whole or in part if they
determine that the product or therapy was not medically appropriate or necessary. Third-party payors may attempt to control costs by
limiting coverage to specific drug products on an approved list, or formulary, which might not include all of the FDA-approved drug
products for a particular indication, and by limiting the amount of reimbursement for particular procedures or drug treatments. In
addition, in the United States, participation in government health programs such as Medicare and Medicaid are subject to complex
rules and controls relating to price reporting and calculation of prices to ensure that pricing provided to government entities for
periodic reporting purposes is aligned and compliant with numerous complex statutory requirements. The infrastructure and/or
external resources necessary to ensure continued compliance with these requirements is extensive and manufacturers are subject to
audit both by the Centers for Medicare and Medicaid Services and by State Medicaid authorities.
The cost of pharmaceuticals and devices continues to generate substantial governmental and third-party payor interest. We
expect that the pharmaceutical industry will experience pricing pressures due to the trend toward managed healthcare, the increasing
influence of managed care organizations and additional legislative proposals. Third-party payors are increasingly challenging the price
and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy.
We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of
our products, in addition to the costs required to obtain the FDA approvals. Our product candidates may not be considered medically
necessary or cost-effective. A payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement
rate will be approved. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to
realize an appropriate return on our investment in product development.
Some third-party payors also require pre-approval of coverage for new or innovative devices or drug therapies before they will
reimburse healthcare providers who use such therapies. While we cannot predict whether any proposed cost-containment measures
will be adopted or otherwise implemented in the future, these requirements or any announcement or adoption of such proposals could
have a material adverse effect on our ability to obtain adequate prices for our product candidates and to operate profitably.
In international markets, reimbursement and healthcare payment systems vary significantly by country, and many countries have
instituted price ceilings on specific products and therapies. There can be no assurance that our products will be considered medically
reasonable and necessary for a specific indication, that our products will be considered cost-effective by third-party payors, that
coverage or an adequate level of reimbursement will be available or that the third-party payors reimbursement policies will not
adversely affect our ability to sell our product profitably.
Healthcare Reform
In the U.S. and foreign jurisdictions, there have been a number of legislative and regulatory changes to the healthcare system
that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives at the U.S.
federal and state levels that seek to reduce healthcare costs. In the U.S., the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, or the Medicare Modernization Act, changed the way Medicare covers and pays for pharmaceutical
products. The Medicare Modernization Act expanded Medicare coverage for drug purchases by the elderly by establishing Medicare
Part D and introduced a new reimbursement methodology based on average sales prices for physician administered drugs under
Medicare Part B. In addition, this legislation provided authority for limiting the number of drugs that will be covered in any
therapeutic class under the new Medicare Part D program. Cost reduction initiatives and other provisions of this legislation could
decrease the coverage and reimbursement rate that we receive for any of our approved products. While the Medicare Modernization
Act applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment
limitations in setting their own reimbursement rates.
Therefore, any reduction in reimbursement that results from the Medicare Modernization Act may result in a similar reduction
in payments from private payors.
In March 2010, President Obama signed into law the ACA, a sweeping law intended to broaden access to health insurance,
reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud and abuse, add new transparency
requirements for healthcare and health insurance industries, impose new taxes and fees on pharmaceutical and medical device
manufacturers and impose additional health policy reforms. We expect that the rebates, discounts, taxes and other costs resulting from
the ACA over time will have a negative effect on our expenses and profitability in the future. Furthermore, expanded government
investigative authority and increased disclosure obligations may increase the cost of compliance with new regulations and programs.
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The current presidential administration and Congress are also expected to continue recent attempts to make changes to the
current health care laws and regulations. The impact of those changes on us and potential effect on the pharmaceutical industry as a
whole is currently unknown. But, any changes to the health care laws or regulations, especially to Medicare drug reimbursement, are
likely to have an impact on our results of operations and may have a material adverse effect on our results of operations. We cannot
predict what other health care programs and regulations will ultimately be implemented at the federal or state level or the effect of any
future legislation or regulation in the United States may have on our business.
It is possible that healthcare reform measures that have been and may be adopted in the future, may result in more rigorous
coverage criteria and in additional downward pressure on the price that we receive for any approved product, and could seriously harm
our future revenue. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in
payments from private payors, and formulary restrictions among private payors including the largest pharmacy benefit managers have
increased over recent months, especially as regards to new and high cost market entrants. The implementation of cost containment
measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our
products.
In addition, different pricing and reimbursement schemes exist in other countries. In the European Community, governments
influence the price of pharmaceutical products through their pricing and reimbursement rules and control of national healthcare
systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems
under which products may be marketed only once a reimbursement price has been agreed upon. Some of these countries may require,
as condition of obtaining reimbursement or pricing approval, the completion of clinical trials that compare the cost- effectiveness of a
particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for
medicines but monitor and control company profits. The downward pressure on healthcare costs in general, particularly prescription
drugs, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in
some countries, cross- border imports from low-priced markets exert a commercial pressure on pricing within a country.
Other Healthcare Laws and Compliance Requirements
In the U.S., the research, manufacturing, distribution, sale and promotion of drug products, including biologics, and medical
devices are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, divisions of the U.S.
Department of Health and Human Services, including the Office of Inspector General and the Centers for Medicare and Medicaid
Services, the U.S. Department of Justice, state Attorneys General, and other state and local government agencies. For example, sales,
marketing and scientific/educational grant programs must comply with fraud and abuse laws such as the federal Anti-Kickback
Statute, as amended, the federal False Claims Act, as amended, and similar state laws. Pricing and rebate programs must comply with
the Medicaid Drug Rebate Program requirements of the Omnibus Budget Reconciliation Act of 1990, as amended, and the Veterans
Health Care Act of 1992, as amended. If products are made available to authorized users of the Federal Supply Schedule of the
General Services Administration, additional laws and requirements apply. All of these activities are also potentially subject to federal
and state consumer protection and unfair competition laws.
The federal Anti-Kickback Statute prohibits any person, including a prescription drug manufacturer (or a party acting on its
behalf), from knowingly and willfully soliciting, receiving, offering or providing remuneration, directly or indirectly, to induce or
reward either the referral of an individual, or the furnishing, recommending, or arranging for a good or service, for which payment
may be made under a federal healthcare program such as the Medicare and Medicaid programs. This statute has been interpreted to
apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, and formulary managers on
the other. The term “remuneration” has been broadly interpreted to include anything of value, including for example, gifts, discounts,
the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of payments, ownership interests and
providing anything at less than its fair market value. Even the award of grant moneys, or the provision of in kind support, publicity
and even authorship, in certain cases, may be deemed to be “remuneration.” Although there are a number of statutory exceptions and
regulatory safe harbors protecting certain business arrangements from prosecution, the exception and safe harbors are drawn narrowly,
and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if
they do not qualify for an exception or safe harbor. Our practices may not in all cases meet all of the criteria for safe harbor protection
from federal Anti-Kickback Statute liability. The reach of the Anti-Kickback Statute was broadened by the recently enacted ACA, so
that the government need no longer prove, for purposes of establishing intent under the federal Anti-Kickback Statute, that a person or
entity had actual knowledge of the statute or specific intent to violate it. In addition, the ACA provides that a violation of the federal
Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act (discussed below).
Additionally, many states have adopted laws similar to the federal Anti-Kickback Statute, and some of these state prohibitions apply
to the referral of patients for healthcare items or services reimbursed by any third-party payor, including private payors. In at least
some cases, these state laws do not contain safe harbors.
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The federal False Claims Act imposes liability on any person or entity that, among other things, knowingly presents, or causes
to be presented, a false or fraudulent claim for payment by a federal healthcare program. The qui tam provisions of the False Claims
Act allow a private individual to bring civil actions on behalf of the federal government and share in any recovery. In recent years, the
number of suits brought by private individuals has increased dramatically. In addition, various states have enacted false claims laws
analogous to the False Claims Act. Many of these state laws apply where a claim is submitted to any third-party payor and not merely
a federal healthcare program. There are many potential bases for liability under the False Claims Act. Liability arises, primarily, when
an entity knowingly submits, or causes another to submit, a false claim for reimbursement to the federal government. The False
Claims Act has been used to assert liability on the basis of inadequate care, kickbacks and other improper referrals, improperly
reported government pricing metrics such as Best Price or Average Manufacturer Price, improper use of Medicare numbers when
detailing the provider of services, improper promotion of off-label uses (i.e., uses not expressly approved by FDA in a drug’s label),
and allegations as to misrepresentations with respect to the services rendered.
Substantial resources have been allocated by both the Department of Justice and the Federal Bureau of Investigation, among
other branches of the US government to identify and investigate possible health care fraud activities. Recent investigations include
those relating to allegedly egregious price increases by manufacturers and alleged fraud involving co-pay arrangements supported by
sponsors. As new theories of liability arise, there is a corresponding cost of doing business in order to maintain compliance.
Our future activities relating to the reporting of discount and rebate information and other information affecting federal,
provincial, state and third party reimbursement of our products, and the sale and marketing of our products and our service
arrangements or data purchases, among other activities, may be subject to scrutiny under these laws. We are unable to predict whether
we would be subject to actions under the False Claims Act or a similar state law, or the impact of such actions. However, the cost of
defending such claims, as well as any sanctions imposed, could adversely affect our financial performance. Also, the Health Insurance
Portability and Accountability Act of 1996 (“HIPAA”), created several new federal crimes including healthcare fraud and false
statements relating to healthcare matters. The healthcare fraud provision of HIPAA prohibits knowingly and willfully executing a
scheme to defraud any healthcare benefit program, including private third-party payors. The false statements provision prohibits
knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent
statement in connection with the delivery of or payment for healthcare benefits, items or services.
In addition, we may be subject to, or our marketing activities may be limited by, data privacy and security regulation by both the
federal government and the states in which we conduct our business. For example, HIPAA and its implementing regulations
established uniform federal standards for certain “covered entities” (healthcare providers, health plans and healthcare clearinghouses)
governing the conduct of certain electronic healthcare transactions and protecting the security and privacy of protected health
information. The American Recovery and Reinvestment Act of 2009, commonly referred to as the economic stimulus package,
included expansion of HIPAA’s privacy and security standards called the Health Information Technology for Economic and Clinical
Health Act (“HITECH”), which became effective on February 17, 2010. Among other things, HITECH makes HIPAA’s privacy and
security standards directly applicable to “business associates”—independent contractors or agents of covered entities that create,
receive, maintain, or transmit protected health information in connection with providing a service for or on behalf of a covered entity.
HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly
other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to
enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions.
There are also an increasing number of state “sunshine” laws that require manufacturers to make reports to states on pricing and
marketing information, as well as regarding payments to healthcare professionals. Several states have enacted legislation requiring
pharmaceutical companies to, among other things, establish marketing compliance programs, file periodic reports with the state, make
periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as
well as to prohibit certain other sales and marketing practices. State laws are not harmonized and contain different reporting
requirements and restrictions which must be noted and adhered to. We currently do not report under these state laws, but will be
required to do if we are successful in obtaining marketing authorization for our products. We will need to develop the infrastructure or
rely on third party contractors to assist us in our compliance with these laws, and failure to comply may result in financial and other
penalties and consequences. In addition, beginning in 2013, a similar “sunshine” federal requirement began requiring manufacturers to
track and report to the federal government certain payments and other transfers of value made to certain covered recipients, including
physicians and other healthcare professionals, and teaching hospitals. In addition to payments, reporting may encompass requirements
to report on ownership or investment interests held by physicians and their immediate family members. The efforts and resources
needed to track and report payments go well beyond our affiliates operating in the United States, as reporting is required also for
payments made by affiliated entities in many cases to US covered recipients. In other jurisdictions (eg, Australia, Japan and Europe)
similar “sunshine-like” laws have also been adopted, which may require disclosure of certain payment and other information to
covered recipients. Extensive administration and systems, including to aggregate and categorize spend, are necessary in order to
enable compliant and timely reporting under these requirements. The US federal government began disclosing the reported
information on a publicly available website in 2014. These laws may affect our development, sales, marketing, and other promotional
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activities by imposing administrative and compliance burdens on us. If we fail to track and report as required by these laws or
otherwise fail to comply with these laws, we could be subject to the penalty and sanctions of the pertinent state and federal authorities.
Because of the breadth of these laws and the narrowness of available statutory and regulatory exemptions, it is possible that
some of our business activities could be subject to challenge under one or more of such laws. If our operations are found to be in
violation of any of the federal and state laws described above or any other governmental regulations that apply to us, we may be
subject to penalties, including criminal and significant civil monetary penalties, damages, fines, imprisonment, exclusion from
participation in government healthcare programs, injunctions, recall or seizure of products, total or partial suspension of production,
denial or withdrawal of premarketing product approvals, private qui tam actions brought by individual whistleblowers in the name of
the government or refusal to allow us to enter into supply contracts, including government contracts, and the curtailment or
restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.
To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which
may include, for instance, applicable post-approval requirements, including safety surveillance, anti-fraud and abuse laws,
implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals.
Australian Disclosure Requirements
Business Strategies and Prospects for Future Years
We are focused on the following core strategic imperatives:
continue to innovate and optimize our disruptive technology platform for cell-based therapeutics;
develop a portfolio of clinically distinct products;
focus on bringing late-stage products to market and portfolio prioritization;
enabling manufacturing scale-up to meet demands of the portfolio;
leverage talent base to continue to establish a culture of shared leadership and accountability;
focus on strategic partnerships;
focus on prudent cash management; and
continue to strengthen our substantial and robust intellectual property estate.
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•
Dividends
No dividends were paid during the course of the fiscal year ended June 30, 2021. There are no dividends or distributions
recommended or declared for payment to members, but not yet paid, during the year.
4.C
Organizational Structure
See “Item 4. Information on the Company – 4.B Business Overview – Overview”, “Item 18. Financial Statements – Note 12”
and Exhibit 8.1 to this Annual Report.
4.D
Property, Plants and Equipment
We lease approximately 11,150 square feet of office space in Melbourne, Australia, where our headquarters are located. We pay
approximately A$1,100,000 per year for this lease, which expires in April 2026. We also lease approximately 15,600 square feet in
New York City, where significant development and commercial activities are conducted. We pay approximately $995,000 per year for
this lease, which expires in September 2024. We also lease laboratory and office space in Singapore. We pay approximately
S$267,000 per year for this lease, which expires in August 2022. We also lease laboratory and office space in Texas and pay
approximately $202,000 per year for this lease, which expires in May 2022. All of our manufacturing operations are currently located
at Lonza’s manufacturing facilities. See “Item 4.B Business Overview – Manufacturing and Supply Chain.”
Item 4A. Unresolved Staff Comments
Not applicable.
65
Item 5.
Operating and Financial Review and Prospects
5.A
Operating Results
This operating and financial review should be read together with our consolidated financial statements in this Annual Report,
which have been prepared in accordance with IFRS as published by the IASB.
Financial Overview
We have incurred significant losses since our inception. We have incurred net losses during most of our fiscal periods since our
inception. For the year ended June 30, 2021, we had an accumulated deficit of $647.6 million. Our net loss for the year ended June 30,
2021 was $98.8 million.
We anticipate that we may continue to incur significant losses for the foreseeable future. There can be no assurance that we will
ever achieve or maintain profitability.
We expect our future capital requirements will continue as we:
•
•
•
•
•
•
•
•
•
•
•
continue the research and clinical development of our product candidates;
initiate and advance our product candidates into larger clinical studies;
seek to identify, assess, acquire, and/or develop other product candidates and technologies;
seek regulatory and marketing approvals in multiple jurisdictions for our product candidates that successfully complete
clinical studies;
establish collaborations with third parties for the development and commercialization of our product candidates, or
otherwise build and maintain a sales, marketing, and distribution infrastructure to commercialize any products for which
we may obtain marketing approval;
further develop and implement our proprietary manufacturing processes and expand our manufacturing capabilities and
resources for commercial production;
seek coverage and reimbursement from third-party payors, including government and private payors for future products;
make interest payments, principal repayments and other charges on our debt financing arrangements;
make milestone or other payments under our agreements pursuant to which we have licensed or acquired rights to
intellectual property and technology;
seek to maintain, protect, and expand our intellectual property portfolio; and
seek to attract and retain skilled personnel.
We expect our research and development and management and administration expenses to remain relatively consistent over the
next 12 months. Subject to us achieving successful regulatory approval, we expect an increase in our total expenses driven by an
increase in our product manufacturing and selling, general and administrative expenses as we move towards commercialization.
Therefore, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, debt
financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and
licensing arrangements. We do not know when, or if, we will generate revenues from our product sales significant enough to generate
profits. We do not expect to generate significant revenue from product sales unless and until we obtain regulatory approval of and
commercialize one or more of our cell-based product candidates. For further discussion on our ability to continue as a going concern,
see Note 1(i) in our accompanying financial statements.
Commercialization and Milestone Revenue. Commercialization and milestone revenue relates to upfront, royalty and milestone
payments recognized under development and commercialization agreements; milestone payments, the receipt of which is dependent
on certain clinical, regulatory or commercial milestones; as well as royalties on product sales of licensed products, if and when such
product sales occur; and revenue from the supply of products. Payment is generally due on standard terms of 30 to 60 days.
66
Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred consideration in our consolidated
balance sheet, depending on the nature of the arrangement. Amounts expected to be recognized as revenue within the 12 months
following the balance sheet date are classified within current liabilities. Amounts not expected to be recognized as revenue within the
12 months following the balance sheet date are classified within non-current liabilities.
In the year ended June 30, 2021, we recognized $7.2 million in commercialization revenue relating to royalty income earned on
sales of TEMCELL® Hs. Inj., a registered trademark of JCR Pharmaceuticals Co. Ltd. (“TEMCELL”), in Japan by our licensee, JCR
Pharmaceuticals Co. Ltd. (“JCR”), compared with $6.6 million for the year ended June 30, 2020. Also in the year ended June 30,
2021, we recognized $0.2 million in commercialization revenue from royalty income earned on sales of Alofisel® in Europe,
compared with a minimal amount in the year ended June 30, 2020. These amounts were recorded in revenue as there are no further
performance obligations required in regard to these items.
In the year ended June 30, 2020, we recognized $15.0 million in milestone revenue for the upfront fee received in October 2019
in relation to our strategic partnership with Grünenthal for the development and commercialization in Europe and Latin America of
our Phase 3 allogeneic MPC product, MPC-06-ID for the treatment of chronic low back pain due to degenerative disc disease in
patients who have exhausted conservative treatment options. This amount was recorded in revenue as the performance obligation in
regards to this milestone had been satisfied as the right of use license of IP had been transferred to Grünenthal upon signing of the
contract. There was no milestone revenue recognized in relation to this strategic partnership with Grünenthal in the year ended June
30, 2021.
In the year ended June 30, 2020, we recognized the remaining $10.0 million in milestone revenue from the $20.0 million upfront
payment received in October 2018 in relation to our strategic alliance with Tasly Pharmaceutical Group (“Tasly”) for the
development, manufacture and commercialization in China of our allogeneic MPC products, MPC-150-IM and MPC-25-IC. Tasly has
received exclusive rights to, and will fund all development, manufacturing and commercialization activities in China for MPC-150-IM
and MPC-25-IC. This amount was recorded in revenue as the control for this portion of revenue was transferred to Tasly during this
period. There was no milestone revenue recognized in relation to this strategic alliance with Tasly in the year ended June 30, 2021.
Interest Revenue. Interest revenue is accrued on a time basis by reference to the principal outstanding and at the effective
interest rate applicable.
Research and Development. Research and development expenditure is recognized as an expense as incurred.
Our research and development expenses consist primarily of:
•
•
•
•
•
third party costs comprising all external expenditure on our research and development programs such as fees paid to
Contract Research Organizations (“CROs”) and on our pre-commercial activities, such as research pertaining to market
access and pricing, brand marketing and initiation of trade and distribution contracts. Third party costs also comprise fees
paid to consultants who perform research on our behalf and under our direction, rent and utility costs for our research and
development facilities, and database analysis fees;
third party costs under license and/or sub-license arrangements for the research and development, license, manufacture
and/or commercialization of products and/or product candidates, such as payments for options to acquire rights to
products and product candidates as well as contingent obligations under the agreements;
product support costs consisting primarily of salaries and related overhead expenses for personnel in research and
development and pre-commercial functions (for example wages, salaries and associated on costs such as superannuation,
share-based incentives and payroll taxes, plus travel costs and recruitment fees for new hires);
intellectual property support costs comprising payments to our patent attorneys to progress patent applications and all
costs of renewing our granted patents; and
amortization of currently marketed products on a straight-line basis over the life of the asset.
Our research and development expenses are not charged to specific products or programs, since the number of clinical and
preclinical product candidates or development projects tends to vary from period to period and since internal resources are utilized
across multiple products and programs over any given period of time. As a result, our management does not maintain and evaluate
research and development costs by product or program. Acquired in-process research and development is capitalized as an asset and is
not amortized but is subject to impairment review during the development phase. Upon completion of its development, the acquired
in-process research and development amortization will commence.
67
Manufacturing Commercialization. Manufacturing commercialization expenditure is recognized as an expense as incurred. Our
manufacturing commercialization expenses consist primarily of:
•
•
•
•
salaries and related overhead expenses including share-based incentives for personnel in manufacturing functions;
fees paid to our contract manufacturing organizations, which perform process development on our behalf and under our
direction;
costs related to laboratory supplies used in our manufacturing development efforts; and
provision for the carrying value of pre-launch inventory costs on the balance sheet.
Management and Administration. Management and administration expenses consist primarily of salaries and related costs
including share-based incentives for employees in executive, corporate and administrative functions. Other significant management
and administration expenses include legal and professional services, rent and depreciation of leasehold improvements, insurance and
information technology services.
Fair Value Remeasurement of Contingent Consideration. Remeasurement of contingent consideration pertains to the acquisition
of assets from Osiris Therapeutics, Inc. (“Osiris”). The fair value remeasurement of contingent consideration is recognized as a net
result of changes to the key assumptions of the contingent consideration valuation such as probability of success, market penetration,
developmental timelines, product pricing, and the increase in valuation as the time period shortens between the valuation date and the
potential settlement dates of contingent consideration. As the net result of changes to the key assumptions and the time period
shortening, we recognized net remeasurement gains of $18.7 million and $1.3 million for the years ended June 30, 2021 and 2020,
respectively.
Other Operating Income and Expenses. Other operating income and expenses primarily comprise foreign exchange gains and
losses.
Foreign exchange gains and losses relate to unrealized foreign exchange gains and losses on our foreign currency amounts in
our Australian based entity, whose functional currency is the A$, and foreign currency amounts in our Switzerland and Singapore
based entities, whose functional currencies are the US$, plus realized gains and losses on any foreign currency payments to our
suppliers due to movements in exchange rates. We recognized foreign exchange gains of $1.5 million and $0.2 million in the years
ended June 30, 2021 and 2020, respectively.
Finance Costs. Finance costs consists of remeasurement of borrowing arrangements, interest expense in relation to finance lease
charges, accrued interest expense and interest expense in relation to the amortization of transaction costs and other charges associated
with the borrowings as represented in our consolidated balance sheet using the effective interest rate method over the period of initial
recognition through maturity.
Remeasurement of borrowing arrangements pertains to our loan and security agreements with Hercules Capital, Inc.
(“Hercules”) and NovaQuest Capital Management, L.L.C. (“NovaQuest”). Remeasurement of borrowing arrangements is recognized
when there is a revision in the estimated future cash flows which is recorded as an adjustment of the carrying amount of the financial
liability. The carrying amount is recalculated by computing the present value of the revised estimated future cash flows at the financial
instrument’s original effective interest rate. In the years ended June 30, 2021 and 2020, we recognized remeasurement gains of $0.4
million and $1.3 million in relation to our existing credit facility with Hercules, respectively. In the years ended June 30, 2021 and
2020, we recognized a remeasurement gain of $4.8 million and a remeasurement loss of $0.7 million in relation to our existing credit
facility with NovaQuest, respectively.
Income Tax Benefit/Expense. Income tax benefit/expense consists of net changes in deferred tax assets and liabilities recognized
on the balance sheet during the period. We recognized a non-cash income tax benefit of $0.8 million in the year ended June 30, 2021
and $9.4 million in the year ended June 30, 2020.
68
Results of Operations
Comparison of Our Results for the Year ended June 30, 2021 with the Year ended June 30, 2020
The following table summarizes our results of operations for the years ended June 30, 2021 and 2020, together with the changes
in those items in dollars and as a percentage.
Year ended
June 30,
2021
2020
$ Change
% Change
(in U.S. dollars, in thousands except per share information)
Consolidated Income Statement Data:
Revenue:
Commercialization revenue
Milestone revenue
Interest revenue
Total revenue
$
$
7,434
—
22
7,456
6,614
25,000
542
32,156
Research & development
Manufacturing commercialization
Management and administration
Fair value remeasurement of contingent consideration
Other operating income and expenses
Finance costs
Loss before income tax
Income tax benefit
Loss attributable to the owners of Mesoblast Limited
(53,012)
(32,719)
(30,867)
18,687
1,539
(10,714)
(99,630)
819
(98,811) $
(56,188)
(25,309)
(25,609)
1,380
324
(14,109)
(87,355)
9,415
(77,940)
$
820
(25,000)
(520)
(24,700)
3,176
(7,410)
(5,258)
17,307
1,215
3,395
(12,275)
(8,596)
(20,871)
12%
(100%)
(96%)
(77%)
(6%)
29%
21%
NM
NM
(24%)
14%
(91%)
27%
Losses per share from continuing operations attributable to
the ordinary equity holders:
Basic - losses per share
Diluted - losses per share
Cents
Cents
Cents
% Change
(16.33)
(16.33)
(14.74)
(14.74)
(1.59)
(1.59)
11%
11%
* NM = not meaningful.
Revenue
Revenues were $7.5 million for the year ended June 30, 2021, compared with $32.2 million for the year ended June 30, 2020, a
decrease of $24.7 million. The following table shows the movement within revenue for the year ended June 30, 2021 and 2020,
together with the changes in those items.
(in U.S. dollars, in thousands)
Revenue:
Commercialization revenue
Milestone revenue
Interest revenue
Revenue
Year ended
June 30,
2021
2020
$ Change
% Change
7,434
—
22
7,456 $
6,614
25,000
542
32,156
820
(25,000)
(520)
(24,700)
12%
(100%)
(96%)
(77%)
$
Commercialization revenue from royalty income earned on sales of TEMCELL in Japan and Alofisel® in Europe increased by
$0.8 million. Royalty income on sales of TEMCELL in Japan by our licensee JCR increased $0.6 million from $6.6 million in the year
ended June 30, 2020 to $7.2 million in the year ended June 30, 2021. Royalty income on sales of Alofisel® in Europe by our licensee
Takeda increased $0.2 million from a minimal amount in the year ended June 30, 2020 to $0.2 million in the year ended June 30,
2021.
We recognized $15.0 million in milestone revenue during the year ended June 30, 2020 for the upfront fee received upon
completion of the strategic partnership with Grünenthal for the development and commercialization in Europe and Latin America of
our Phase 3 allogeneic MPC product, MPC-06-ID. Additionally, we recognized $10.0 million in milestone revenue during the year
ended June 30, 2020 due to the recognition of the remaining $10.0 million from the $20.0 million upfront technology access fee
received in October 2018 in relation to our strategic alliance with Tasly for the development, manufacture and commercialization in
69
China of our allogenic MPC products, MPC-150-IM and MPC-25-IC. No milestone revenue was recognized in the year ended June
30, 2021.
The $0.5 million decrease in interest revenue for the year ended June 30, 2021, compared with the year ended June 30, 2020 was
primarily driven by lower interest rates on US$ cash deposits in the year ended June 30, 2021, when compared with the year ended
June 30, 2020.
Research and development
Research and development expenses were $53.0 million for the year ended June 30, 2021, compared with $56.2 million for the
year ended June 30, 2020, a decrease of $3.2 million. The $3.2 million decrease in research and development expenses primarily
reflects a decrease in third party costs partially offset by an increase in product support costs.
(in U.S. dollars, in thousands)
Research and development:
Third party costs
Product support costs
Intellectual property support costs
Amortization of current marketed products
Research and development
Year ended
June 30,
2021
2020
$ Change
% Change
19,269
29,649
2,635
1,459
53,012 $
26,912
24,995
2,826
1,455
56,188
(7,643)
4,654
(191)
4
(3,176)
$
(28%)
19%
(7%)
0%
(6%)
Third party costs, which consist of all external expenditure on our research and development programs, decreased by $7.6
million in the year ended June 30, 2021 compared with the year ended June 30, 2020.
This $7.6 million decrease was due to a reduction in our third party costs for our Phase 3 clinical trials for MPC-150-IM (CHF),
MPC-06-ID (CLBP) and remestemcel-L (for pediatric SR-aGVHD) as activities and costs have reduced as enrollment was completed
in January 2019, March 2018 and December 2017, respectively. We continued to incur costs for MPC-150-IM (CHF) and MPC-06-ID
(CLBP) during the year ended June 30, 2021 as patients were monitored during follow up visits, other testing was completed and data
was analyzed. In the year ended June 30, 2021, there was an increase in third party costs associated with clinical enrollment and
patient monitor for our Phase 3 clinical trial for the treatment of ARDS in COVID-19 patients. This trial commenced in April 2020
and enrollment was completed in December 2020. In the year ended June 30, 2021, we also incurred costs of $1.7 million associated
with our pre-commercial activities as we prepared for the potential launch of remestemcel-L in the United States.
Product support costs, which consist primarily of salaries and related overhead expenses for personnel in research and
development and pre-commercial functions, have increased by $4.6 million, for the year ended June 30, 2021 compared with the year
ended June 30, 2020. Within this $4.6 million increase, $5.1 million relates to an increase in product support costs for research and
development functions and $0.5 million relates to a decrease in product support costs for pre-commercial functions.
The $5.1 million increase in product support costs for personnel in research and development functions is primarily due to an
increase of $1.5 million across salaries and associated costs as full time equivalents increased by 4.3 (8%) from 51.2 for the year
ended June 30, 2020 to 55.5 for the year ended June 30, 2021. There was also an increase of $0.4 million in consulting expenses and
$4.2 million in share-based payment expenses for the year ended June 30, 2021 compared with the year ended June 30, 2020. These
increases were offset by a decrease of $0.6 million in travel expenses and $0.4 million in recruitment expenses in the year ended June
30, 2021 compared with the year ended June 30, 2020.
The $0.5 million decrease in product support costs for personnel in pre-commercial functions is primarily due to a decrease of
$0.4 million in share-based payment expenses and $0.4 million across recruitment and travel expenses in the year ended June 30, 2021
compared with the year ended June 30, 2020. These decreases were offset by an increase of $0.1 million in consulting expenses for the
year ended June 30, 2021 compared with the year ended June 30, 2020. The full time equivalents remained relatively consistent from
7.6 for the year ended June 30, 2020 to 7.5 for the year ended June 30, 2021; however overall costs of salaries and associated expenses
increased by $0.2 million due to one-off restructuring costs during the year ended June 30, 2021 compared with the year ended June
30, 2020.
Also included in research and development expenses are intellectual property support costs, which consist of payments to our
patent attorneys to progress patent applications and costs of renewing our granted patents. These costs have decreased by $0.2 million
in the year ended June 30, 2021 compared with the year ended June 30, 2020 due to decreased activities across our MSC-based patent
portfolio.
70
Manufacturing commercialization
Manufacturing commercialization expenses were $32.7 million for the year ended June 30, 2021, compared with $25.3 million
for the year ended June 30, 2020, an increase of $7.4 million as we invested in manufacturing of remestemcel-L as part of our
readiness strategy for potential FDA approval and incurred costs on potency assay work that will support both the aGVHD Biologics
License Application (“BLA”) resubmission and the Investigational New Drug (“IND”) for the Phase 3 trial COVID ARDS and
completed process development to increase yields necessary for long-term commercial supply.
(in U.S. dollars, in thousands)
Manufacturing commercialization:
Platform technology
Manufacturing support costs
Manufacturing commercialization
$
Year ended
June 30,
2021
2020
$ Change
% Change
30,842
1,877
32,719 $
23,342
1,967
25,309
7,500
(90)
7,410
32%
(5%)
29%
Platform technology costs, which consist of fees paid to our contract manufacturing organizations and for laboratory supplies
used in manufacturing commercialization of our MPC and MSC based products, increased by $7.5 million for the year ended June 30,
2021 compared with year ended June 30, 2020. The increase was primarily due to increased spend for manufacturing of remestemcel-
L as part of our readiness strategy for potential FDA approval, potency assay work that will support both the aGVHD BLA
resubmission and the IND for the Phase 3 trial COVID ARDS and increased costs for process development of our proprietary
technology that facilitates the increase in yields necessary for the long-term commercial supply of its product candidates, and next
generation manufacturing processes to reduce labor, drive down cost of goods and improve manufacturing efficiencies.
Manufacturing support costs, which consist primarily of salaries and related overhead expenses for personnel in manufacturing
commercialization functions remained relatively consistent for the year ended June 30, 2021 compared with the year ended June 30,
2020.
Management and administration
Management and administration expenses were $30.9 million for the year ended June 30, 2021, compared with $25.6 million for
the year ended June 30, 2020, an increase of $5.3 million. This increase was primarily due to an increase in share-based payments and
legal and professional fees.
(in U.S. dollars, in thousands)
Management and administration:
Labor and associated expenses
Corporate overheads
Legal and professional fees
Management and administration
$
Year ended
June 30,
2021
2020
$ Change
% Change
13,935
10,690
6,242
30,867 $
13,409
8,891
3,309
25,609
526
1,799
2,933
5,258
4%
20%
89%
21%
Labor and associated expenses increased by $0.5 million from $13.4 million for the year ended June 30, 2020 to $13.9 million
for the year ended June 30, 2021. This $0.5 million increase in the year ended June 30, 2021 is primarily due to an increase of $0.7
million in share-based payment expenses and $0.2 million in director fees. These increases were offset by a decrease of $0.5 million in
consulting expenses and $0.3 million in recruitment. There was also a decrease in overall costs of salaries and associated expenses by
$0.5 million in the year ended June 30, 2021, compared with the year ended June 30, 2020 due to full time equivalents decreasing by
0.5 (2%) from 26.9 for the year ended June 30, 2020 to 26.4 for the year ended June 30, 2021. Labor and associated expenses also
experienced unfavorable exchange rate fluctuations of $0.9 million in the year ended June 30, 2021 compared with the year ended
June 30, 2020, as the A$ strengthened against the US$ given the majority of management and administration expenses are incurred in
A$ by our headquarter office located in Australia.
Corporate overhead expenses increased by $1.8 million from $8.9 million for the year ended June 30, 2020 to $10.7 million for
the year ended June 30, 2021 primarily due to an increase in insurance premiums and depreciation expenses.
Legal and professional fees increased by $2.9 million from $3.3 million for the year ended June 30, 2020 to $6.2 million for the
year ended June 30, 2021 primarily due to increased legal and other advisory fees associated with one-off regulatory, partnering and
financing activities incurred during the year ended June 30, 2021.
71
Fair value remeasurement of contingent consideration
Fair value remeasurement of contingent consideration was a $18.7 million gain for the year ended June 30, 2021 compared with
a $1.3 million gain for the year ended June 30, 2020. The $18.7 million gain for the year ended June 30, 2021 was due to the
remeasurement of contingent consideration pertaining to the acquisition of assets from Osiris. This gain was a net result of changing
the key assumptions of the contingent consideration valuation such as probability of success and development timelines primarily as a
result of receiving the Complete Response Letter from the FDA on the BLA for remestemcel-L for the treatment of pediatric SR-
aGVHD on September 30, 2020.
The $1.3 million gain for the year ended June 30, 2020 was due to the remeasurement of contingent consideration pertaining to
the acquisition of assets from Osiris. This gain is a net result of changes to the key assumptions of the contingent consideration
valuation such as development timelines, market penetration, product pricing and the increase in valuation as the time period shortens
between the valuation date and the potential settlement dates of contingent consideration.
With respect to future milestone payments, contingent consideration will be payable in cash or shares at our discretion. With
respect to commercialization, product royalties will be payable in cash which will be funded from royalties received from net sales.
Other operating income and expenses
In other operating income and expenses, we recognized income of $1.5 million for the year ended June 30, 2021, compared with
$0.3 million for the year ended June 30, 2020, an increase in income of $1.2 million. The following table shows movements within
other operating income and expenses for the year ended June 30, 2021 and 2020, together with the changes in those items:
(in U.S. dollars, in thousands)
Other operating income and expenses:
Foreign exchange (gains)/losses (net)
Government grant revenue
Other operating (income) and expenses
$
Year ended
June 30,
2021
2020
$ Change
% Change
(1,471)
(68)
(1,539) $
(246)
(78)
(324)
(1,225)
10
(1,215)
NM
(13%)
NM
* NM = not meaningful.
We are subject to foreign exchange gains and losses on foreign currency cash balances, creditors and debtors. In the year ended
June 30, 2020, we recognized a foreign exchange gain of $0.2 million. In the year ended June 30, 2021, we recognized a foreign
exchange gain of $1.5 million, primarily due to movements in exchange rates on US$ deposits held in Mesoblast Limited, whose
functional currency is the A$, as the A$ appreciated against the US$.
Finance costs
(in U.S. dollars, in thousands)
Finance costs:
Year ended
June 30,
2021
2020
$ Change
% Change
Remeasurement of borrowing arrangements
Interest expense
Finance costs
(5,225)
15,939
10,714 $
(607)
14,716
14,109
(4,618)
1,223
(3,395)
$
NM
8%
(24%)
* NM = not meaningful.
In the year ended June 30, 2021, we recognized an overall $5.2 million gain for remeasurement of borrowing arrangements in
relation to the adjustment of the carrying amount of our financial liability to reflect the revised estimated future cash flows from our
existing credit facilities with Hercules and NovaQuest, an increase of $4.6 million as compared with a $0.6 million gain for the year
ended June 30, 2020.
Within the $5.2 million gain in the year ended June 30, 2021, we recognized a $4.8 million gain for remeasurement of
borrowing arrangements in relation to the adjustment of the carrying amount of our financial liability to reflect the revised estimated
future cash flows as a net result of changes to the key assumption in development timelines in relation to our existing credit facility
with NovaQuest. In the year ended June 30, 2020, we recognized a $0.7 million loss for remeasurement of borrowing arrangements in
72
relation to the adjustment of the carrying amount of our financial liability to reflect the revised estimated future cash flows in relation
to our existing credit facility with NovaQuest.
Also within the $5.2 million gain in the year ended June 30, 2021, we recognized a gain of $0.4 million for remeasurement of
borrowing arrangements in relation to the adjustment of the carrying amount of our financial liability to reflect the revised estimated
future cash flows from our existing credit facilities with Hercules, a decrease of $0.9 million as compared with a gain of $1.3 million
for the year ended June 30, 2020.
Interest expense increased by $1.2 million from $14.7 million for the year ended June 30, 2020 to $15.9 million for the year
ended June 30, 2021.
Within the $15.9 million interest expenses in the year ended June 30, 2021, we recognized $8.3 million of interest expense in
relation to our loan and security agreement with Hercules, an increase of $0.3 million as compared with $8.0 million for the year
ended June 30, 2020. Within this $8.3 million recognized in the year ended June 30, 2021, $4.9 million was recognized with regard to
interest expense payable on the loan balance within the year and a further $3.4 million of interest expense was recognized with regard
to the amortization of transaction costs incurred on the outstanding loan principal for the year ended June 30, 2021 using the effective
interest rate method over the period of initial recognition through maturity.
Also within the $15.9 million interest expense in the year ended June 30, 2021, we recognized $7.0 million of interest expense
in relation to our loan and security agreement with NovaQuest, an increase of $0.8 million as compared with $6.2 million for the year
ended June 30, 2020. Interest expense relating to the NovaQuest loan are accrued on the loan principal balance and all interest
payments will be deferred until after the first commercial sale of our allogeneic product candidate remestemcel-L for the treatment of
pediatric patients with SR-aGVHD in the United States and other geographies excluding Asia (“pediatric SR-aGVHD”).
In the years ended June 30, 2021 and 2020, in line with IFRS 16 Leases, we also recognized interest expense of $0.6 million and
$0.5 million in relation to lease charges, respectively.
Loss after income tax
(in U.S. dollars, in thousands)
Loss before income tax
Income tax benefit
Loss after income tax
Year ended
June 30,
2021
(99,630)
819
(98,811) $
2020
(87,355)
9,415
(77,940)
$
$ Change
% Change
(12,275)
(8,596)
(20,871)
14%
(91%)
27%
Loss before income tax was $99.6 million for the year ended June 30, 2021 compared with $87.3 million for the year ended
June 30, 2020, an increase in the loss by $12.3 million. This increase is the net effect of the changes in revenues and expenses that
have been discussed above.
A non-cash income tax benefit of $0.8 million was recognized in the year ended June 30, 2021, in relation to the net change in
deferred tax assets and liabilities recognized on the balance sheet during the period.
A non-cash income tax benefit of $9.4 million was recognized in the year ended June 30, 2020 in relation to the net change in
deferred tax assets and liabilities recognized on the balance sheet during the period.
Comparison of Our Results for the Year ended June 30, 2020 with the Year ended June 30, 2019
For results of operations for the years ended June 30, 2020 and 2019, together with the changes in those items in dollars and as a
percentage and the related discussions on these results, refer to Results of Operations within “Item 5.A Operating Results” in our
annual report on Form 20-F for the year ended June 30, 2020, filed with the SEC on September 3, 2020.
Certain Differences Between IFRS and U.S. GAAP
IFRS differs from U.S. GAAP in certain respects. Management has not assessed the materiality of differences between IFRS
and U.S. GAAP. Our significant accounting policies are described in “Item 18 Financial Statements – Note 22”.
73
Quantitative and Qualitative Disclosure about Market Risk
The following sections provide quantitative information on our exposure to interest rate risk, share price risk, and foreign
currency exchange risk. We make use of sensitivity analyses which are inherently limited in estimating actual losses in fair value that
can occur from changes in market conditions. For further assessment on our market risks, see “Item 18. Financial Statements – Note
10(a).”
Foreign currency exchange risk
We have foreign currency amounts owing relating to clinical, regulatory and overhead activities and foreign currency deposits
held primarily in our Australian based entity, whose functional currency is the A$. We also have foreign currency amounts in our
Switzerland and Singapore based entities, whose functional currencies are the US$. These foreign currency balances give rise to a
currency risk, which is the risk of the exchange rate moving, in either direction, and the impact it may have on our financial
performance.
We manage the currency risk by evaluating levels to hold in each currency by assessing our future activities which will likely be
incurred in those currencies which enables us to minimize foreign currency deposits held in each entity.
Interest rate risk
Our main interest rate risk arises from the portion of our long-term borrowings with a floating interest rate, which exposes us to
cash flow interest rate risk. As interest rates fluctuate, the amount of interest payable on financing where the interest rate is not fixed
will also fluctuate. Interest rate risk can be managed by interest rate swaps, which can be entered into to convert the floating interest
rate to a fixed interest rate as required. Additionally, we can repay the loan facility at our discretion and we can also refinance if we
are able to achieve terms suitable to us in the marketplace or from our existing lenders.
Upon entering the agreement with Hercules, we completed a cost benefit analysis of entering an interest rate swap arrangement.
We did not enter into any interest rate swaps during the year ended June 30, 2021.
We are also exposed to interest rate risk that arises through movements in interest income we earn on our deposits. The interest
income derived from these balances can fluctuate due to interest rate changes. This interest rate risk is managed by periodically
reviewing interest rates available for suitable interest bearing accounts to ensure we earn interest at market rates. We ensure that
sufficient funds are available, in at call accounts, to meet our working capital requirements.
Price risk
Price risk is the risk that future cash flows derived from financial instruments will be altered as a result of a market price
movement, which is defined as movements other than foreign currency rates and interest rates. We are exposed to price risk which
arises from long-term borrowings under our facility with NovaQuest, where the timing and amount of principal and interest payments
is dependent on net sales of remestemcel-L for the treatment of pediatric SR-aGVHD. As net sales of remestemcel-L for the treatment
of SR-aGVHD in pediatric patients in these territories increase/decrease, the timing and amount of principal and interest payments
relating to this type of financing arrangement will also fluctuate, resulting in an adjustment to the carrying amount of the financial
liability. The adjustment is recognized in the Income Statement as remeasurement of borrowing arrangements within finance costs and
expenses in the period the revision is made.
We are also exposed to price risk on contingent consideration provision balances, as expected unit revenues are a significant
unobservable input used in the level 3 fair value measurements.
We do not consider any exposure to price risk other than those already described above.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, other than the
purchase commitments and contingent liabilities as mentioned below.
74
Contractual Obligations and Commitments
Contractual commitments:
Purchase commitments means an agreement to purchase goods or services that is enforceable and legally binding that specifies
all significant terms, including: fixed or minimum quantities to be purchased; fixed, minimum or variable price provisions; and the
approximate timing of the transaction. Purchase obligations are not recognized as liabilities at June 30, 2021.
In December 2019, we commenced production under our manufacturing service agreement with Lonza for the supply of
commercial product for the potential approval and launch of remestemcel-L for the treatment of pediatric SR-aGVHD in the US
market. As a result of receiving the Complete Response Letter from the FDA on the BLA for remestemcel-L on September 30, 2020,
in March 2021 we entered an agreement to reduce the remaining minimum financial commitment of our manufacturing service
agreement with Lonza through to November 2021, with an option to extend the non-cancellable term to June 2024 at our discretion. In
June 2021, we exercised the option to extend the non-cancellable term of this agreement to June 2024.
This agreement contains lease and non-lease components. As of June 2021, the agreement contains a minimum remaining
financial commitment of the non-lease component of $24.0 million, disclosed within the total contractual cashflows on an
undiscounted basis as purchase commitments. We have accounted for the lease component within the agreement as a lease liability
separately from the non-lease components. As of June 30, 2021, the minimum financial commitment of the lease component is $5.0
million on an undiscounted basis, as disclosed within the total contractual cash flows as lease liabilities.
We have agreements with third parties related to contract manufacturing and other goods and services. As of June 30, 2021, we
had $9.6 million of non-cancellable purchase commitments related to raw materials, manufacturing agreements and other goods and
services, which are expected to be paid through 2022. This amount represents our minimum contractual obligations, including
termination fees. Certain agreements provide for termination rights subject to termination fees. Under such agreement, we are
contractually obligated to make certain payments, mainly, to reimburse them for their unrecoverable outlays incurred prior to
cancellation.
We do not have any other purchase commitments as of June 30, 2021.
Lease commitment – as lessee:
We lease various offices under non-cancellable leases expiring within 1 to 5 years. The leases have varying terms, escalation
clauses and renewal rights. On renewal, the terms of the leases are renegotiated. We also lease a manufacturing suite under the non-
cancellable manufacturing services agreement with Lonza for the supply of commercial product for the potential approval and launch
of remestemcel-L for the treatment of pediatric SR-aGVHD in the US market expiring within 3 years.
Contingent liabilities
We acquired certain intellectual property relating to our MPCs, or Medvet IP, pursuant to an Intellectual Property Assignment
Deed, or IP Deed, with Medvet Science Pty Ltd, or Medvet. Medvet’s rights under the IP Deed were transferred to Central Adelaide
Local Health Network Incorporated, or CALHNI, in November 2011. In connection with our use of the Medvet IP, on completion of
certain milestones we will be obligated to pay CALHNI, as successor in interest to Medvet, (i) certain aggregated milestone payments
of up to $2.2 million and single-digit royalties on net sales of products covered by the Medvet IP, for cardiac muscle and blood vessel
applications and bone and cartilage regeneration and repair applications, subject to minimum annual royalties beginning in the first
year of commercial sale of those products and (ii) single-digit royalties on net sales of the specified products for applications outside
the specified fields.
We have entered into a number of agreements with other third parties pertaining to intellectual property. Contingent liabilities
may arise in the future if certain events or developments occur in relation to these agreements and as of June 30, 2021 we have
assessed that the probability of outflows is remote.
Capital commitments
We did not have any commitments for future capital expenditure outstanding as of June 30, 2021.
75
Australian Disclosure Requirements
Significant Changes in the State of Affairs
There have been no significant changes within the state of our affairs during the year ended June 30, 2021 except as noted in the
“Important Corporate Developments” section included in Item 4.A.
Likely Developments and Expected Results of Operations
In September 2020, the U.S. Food and Drug Administration (“FDA”) issued a Complete Response Letter to our Biologics
License Application (“BLA”) filing of remestemcel-L for the treatment of children with steroid-refractory acute graft versus host
disease (“SR-aGVHD”), a life-threatening complication of an allogeneic bone marrow transplant. Despite the overwhelming
Oncologic Drugs Advisory Committee (“ODAC”) of the FDA vote in August 2020, the FDA recommended that we conduct at least
one additional randomized, controlled study in adults and/or children to provide further evidence of effectiveness of remestemcel-L
for SR-aGVHD. We continue to be in discussion with the FDA through a well-established regulatory process that may include a
resubmission with a six month review with the aim of achieving approval of remestemcel-L in the treatment of SR-aGVHD in
children.
Other significant milestones are expected in the upcoming financial year in relation to our other Tier 1 product candidates, as
detailed elsewhere in this report.
Environmental Regulations
Our operations are not subject to any significant environmental regulations under either Commonwealth of Australia or
State/Territory legislation. We consider that adequate systems are in place to manage our obligations and are not aware of any breach
of environmental requirements pertaining to us.
5.B
Liquidity and Capital Resources
Sources of Liquidity
We held total cash and cash equivalents of $136.9 million as of June 30, 2021. Over the next twelve months in order to meet our
forecast expenditure, including repayment of the Hercules debt facility, cash inflows will be required. Management and the directors
believe we will achieve this given plans to complete either one or more strategic partnerships or restructure existing loan agreements,
and have prepared the financial report on a going concern basis. The dependency on these planned objectives indicates material
uncertainty which may cast significant doubt (or substantial doubt as contemplated by Public Company Accounting Oversight Board
(“PCAOB”) standards) on our ability to continue as a going concern and that we may be unable to realize our assets and discharge our
liabilities in the normal course of business. For our audited financial statements, see “Item 18 Financial Statements” included in our
Form 20-F.
Our primary sources of liquidity have historically been equity raisings, upfront and milestone payments from strategic license
agreements and borrowings under our loan agreements. We also expect net sales to become a source of liquidity. While in the long-
term we expect to be able to complete transactions, draw upon these facilities and achieve approval of our product candidates to
provide liquidity as needed, there can be no assurance as to whether we will be successful or, if successful, what the terms or proceeds
may be.
Cash flows
(in U.S. dollars, in thousands)
Cash Flow Data:
Net cash (outflows) in operating activities
Net cash (outflows) in investing activities
Net cash inflows by financing activities
Net increase in cash and cash equivalents
Year ended
June 30,
2021
2020
$ Change
% Change
(106,681)
(1,647)
114,466
6,138
(56,365)
(3,273)
137,044
77,406
(50,316)
1,626
(22,578)
(71,268)
89%
(50%)
(16%)
(92%)
76
Comparison of cash flows for the Year ended June 30, 2021 with the Year ended June 30, 2020
Net cash outflows in operating activities
Net cash outflows for operating activities were $106.7 million for the year ended June 30, 2021, compared with $56.4 million
for the year ended June 30, 2020, an increase of $50.3 million. The increase of $50.3 million is due to an increase in cash outflows of
$29.2 million and a decrease in cash inflows of $21.1 million in the year ended June 30, 2021 compared with the year ended June 30,
2020.
The $21.1 million decrease of inflows comprised: inflows from upfront fee and milestone payment received in relation to the
strategic partnership with Grünenthal decreased by $17.5 million in the year ended June 30, 2021 compared with the year ended June
30, 2020; receipts for the research and development tax incentive decreased by $1.5 million in the year ended June 30, 2021 compared
with the year ended June 30, 2020; inflows from royalty income earned on sales of TEMCELL in Japan decreased by $1.6 million
during the year ended June 30, 2021, compared with the year ended June 30, 2020; and inflows from interest receipts reduced by $0.5
million in the year ended June 30, 2021 compared with the year ended June 30, 2020.
Outflows for payments to suppliers and employees and interest and other costs of finance paid increased by $29.2 million from
$83.7 million for the year ended June 30, 2020 to $112.9 million for the year ended June 30, 2021 primarily due to an increase in
payments in relation to product manufacturing and operating costs and research and development costs.
Net cash inflows in investing activities
Net cash outflows for investing activities decreased by $1.6 million for the year ended June 30, 2021, compared with the year
ended June 30, 2020 primarily due to a $0.6 million decrease in payments for fixed assets, such as plant and equipment and
intellectual property and a $1.0 million decrease in payments for contingent consideration in the year ended June 30, 2021 compared
with the year ended June 30, 2020.
Net cash inflows in financing activities
Net cash inflows for financing activities decreased by $22.6 million for the year ended June 30, 2021, compared with the year
ended June 30, 2020. In the year ended June 30, 2020, we received a $50.6 million receipt of gross proceeds from a share placement to
existing and new Australian and global institutional investors completed in October 2019, and proceeds of $89.9 million from share
placements to existing and new institutional investors in May 2020. In the year ended June 30, 2021, we received $108.6 million of
proceeds from a private placement completed in March 2021. We received $9.2 million in receipts from employee share option
exercises during the year ended June 30, 2021, compared to $4.4 million for the year ended June 30, 2020. In the year ended June 30,
2021, we received receipts of $1.4 million for shares issued through the exercise of incentive rights in connection with the Kentgrove
Capital equity facility agreement. These receipts were offset by a $2.9 million payment for lease liabilities during the year ended June
30, 2021, compared to $1.6 million for the year ended June 30, 2020. Additionally, there were $1.8 million and $6.3 million of
payments for associated capital raising costs in the year ended June 30, 2021 and 2020, respectively.
Comparison of cash flows for the Year ended June 30, 2020 with the Year ended June 30, 2019
For discussion on comparison of cash flows for the years ended June 30, 2020 and 2019, refer to Cash Flows within “Item 5.B
Liquidity and Capital Resources” in our annual report on Form 20-F for the year ended June 30, 2020, filed with the SEC on
September 3, 2020.
Operating Capital Requirements
We do not know when, or if, we will generate revenues from our product sales significant enough to generate profits. We do not
expect to generate significant revenue from product sales unless and until we obtain regulatory approval of and commercialize more of
our cell-based product candidates. We anticipate that we will continue to incur losses for the foreseeable future, and we expect the
losses to increase as we continue the development of, and seek regulatory approvals for, our cell-based product candidates, and begin
to commercialize any approved products either directly ourselves or through a collaborator or partner. We are subject to all of the risks
inherent in the development of new cell-based products, and we may encounter unforeseen expenses, difficulties, complications,
delays and other unknown factors that may adversely affect our business. We anticipate that we will need substantial additional
funding in connection with our continuing operations.
We expect that our research and development expenses and our management and administration expenses to remain relatively
consistent over the next 12 months. Subject to us achieving successful regulatory approval we expect an increase in our total expenses
driven by an increase in our product manufacturing and selling, general and administrative expenses as we move towards
commercialization. Therefore, we will need additional capital to fund our operations, which we may raise through a combination of
77
equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic
alliances and licensing arrangements.
Additional capital may not be available on reasonable terms, if at all. If we are unable to raise additional capital in sufficient
amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or
commercialization of one or more of our product candidates. If we raise additional funds through the issuance of additional debt or
equity securities, it could result in dilution to our existing shareholders, increased fixed payment obligations and the existence of
securities with rights that may be senior to those of our ordinary shares. If we incur further indebtedness, we could become subject to
covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur
additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that
could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial
condition and prospects.
Borrowings
Hercules
In March 2018, we entered into a loan and security agreement with Hercules, for a $75.0 million non-dilutive, four-year credit
facility. We drew the first tranche of $35.0 million on closing and a further tranche of $15.0 million was drawn in January 2019. The
loan matures in March 2022.
In May 2021, we amended the terms of the loan and security agreement to extend the interest-only period to October 1, 2021. In
August 2021, we amended the terms of the loan and security agreement to extend the interest-only period to January 1, 2022. Principal
repayments can be further deferred to March 2022, subject to achieving certain milestones.
Interest on the loan is payable monthly in arrears on the 1st day of the month. At closing date, the interest rate was 9.45% per
annum. At June 30, 2019, in line with increases in the U.S. prime rate, the interest rate was 10.45%. On August 1, September 19 and
October 31, in line with the decreases in the U.S. prime rate, the interest rate on the loan decreased to 10.20%, 9.95% and 9.70%,
respectively, and remains at 9.70% at June 30, 2021 in line with the terms of the loan agreement. As at June 30, 2021, we recognized
$2.2 million in interest payable within twelve months as a current liability.
In the years ended June 30, 2021 and 2020, we recognized gains of $0.4 million and $1.3 million, respectively, in the Income
Statement as remeasurement of borrowing arrangements within finance costs. These remeasurements relate to adjustments of the
carrying amount of our financial liability to reflect the revised estimated future cash flows from our existing credit facility.
NovaQuest
On June 29, 2018, we drew the first tranche of $30.0 million of the principal amount from the $40.0 million loan and security
agreement with NovaQuest. There is a four-year interest only period, until July 2022, with the principal repayable in equal quarterly
instalments over the remaining period of the loan. The loan matures in July 2026. Interest on the loan will accrue at a fixed rate of
15% per annum.
All interest and principal payments will be deferred until after the first commercial sale of remestemcel-L for the treatment in
pediatric SR-aGVHD. We can elect to prepay all outstanding amounts owing at any time prior to maturity, subject to a prepayment
charge, and may decide to do so if net sales of remestemcel-L for pediatric SR-aGVHD are significantly higher than current forecasts.
If there are no net sales of remestemcel-L for pediatric SR-aGVHD, the loan is only repayable on maturity in 2026. If in any
annual period 25% of net sales of remestemcel-L for pediatric SR-aGVHD exceed the amount of accrued interest owing and, from
2022, principal and accrued interest owing (“the payment cap”), Mesoblast will pay the payment cap and an additional portion of
excess sales which may be used for early prepayment of the loan. If in any annual period 25% of net sales of remestemcel-L for
pediatric SR-aGVHD is less than the payment cap, then the payment is limited to 25% of net sales of remestemcel-L for pediatric SR-
aGVHD. Any unpaid interest will be added to the principal amounts owing and shall accrue further interest. At maturity date, any
unpaid loan balances are repaid.
Because of this relationship of net sales and repayments, changes in our estimated net sales may trigger an adjustment of the
carrying amount of the financial liability to reflect the revised estimated cash flows. The carrying amount adjustment is recalculated
by computing the present value of the revised estimated future cash flows at the financial instrument’s original effective interest rate.
The adjustment is recognized in the Income Statement as remeasurement of borrowing arrangements within finance costs in the period
the revision is made.
In the year ended June 30, 2021, we recognized a gain of $4.8 million in the Income Statement as remeasurement of borrowing
arrangements within finance costs in relation to the adjustment of the carrying amount of our financial liability to reflect the revised
estimated future cash flows as a net result of changes to the key assumptions in development timelines. In the year ended June 30,
78
2020, we recognized a loss of $0.7 million in the Income Statement as remeasurement of borrowing arrangements within finance costs
in relation to the adjustment of the carrying amount of our financial liability to reflect the revised estimated future cash flows.
As at June 30, 2021, we recognized a current liability of $0.3 million which represents the present value of $0.4 million loan
administration fee which is payable annually in June.
The carrying amount of the loan and security agreement with NovaQuest is subordinated to our floating rate loan with our senior
creditor, Hercules.
Compliance with loan covenants
Our loan facilities with Hercules and NovaQuest contain a number of covenants that impose operating restrictions on us, which
may restrict our ability to respond to changes in our business or take specified actions. We have an operating objective to at all times
maintain unrestricted cash reserves in excess of six months liquidity. The objective aligns with our loan and security agreement with
Hercules where we are obliged to maintain certain levels of cash in the United States, and a minimum unrestricted cash balance equal
to the lessor of: four months liquidity (defined as the prior four calendar months net cash outflows in operating activities and investing
activities, excluding amounts for extraordinary, non-recurring, not regularly scheduled or onetime proceeds and amounts) plus any
balance of accounts payable not paid after the 120th day following the invoice date for such accounts payable; and the outstanding
loan balance.
We have complied with the financial and other restrictive covenants of our borrowing facilities during the year ended June 30,
2021 and during the year ended June 30, 2020.
5.C
Research and Development, Patents and Licenses
For a description of the amount spent during each of the last two fiscal years on company-sponsored research and development
activities, as well as the components of research and development expenses, see “Item 5.A Operating Results – Results of
Operations.”
For a description of our research and development process, see “Item 4.B Business Overview.”
5.D
Trend Information
As a biotechnology company which primarily is still in the development stage, we are subject to costs of our clinical trials and
other work necessary to support applications for regulatory approval of our product candidates. Health regulators have increased their
focus on product safety. In addition, regulators have also increased their attention on whether or not a new product offers evidence of
substantial treatment effect. These developments have led to requests for more clinical trial data, for the inclusion of a higher number
of patients in clinical trials, and for more detailed analyses of the trials. In light of these developments, we expect these aspects of our
research and development expenses may need to increase as we continue to fund our programs to the market. Notwithstanding this
upward trend, our research and development expenses may still fluctuate from period to period due to varied rates of patient
enrollment and the timing of our clinical trials as our existing trials are completed and new trials commence. We cannot predict with
any degree of accuracy the outcome of our research or commercialization efforts.
5.E
Critical Accounting Estimates
Not applicable.
79
Item 6.
Directors, Senior Management and Employees
(Start of the Remuneration Report for Australian Disclosure Requirements)
The Mesoblast board of directors (“the Board”) presents the 2020/2021 Remuneration Report, which has been prepared in
accordance with the relevant Corporations Act 2001 (“Corporations Act”) and accounting standards requirements.
The remuneration report sets out remuneration information for our company’s key management personnel (“KMP”) as defined
in the International Accounting Standards 24 ‘Related Party Disclosures’ and the Australian Corporations Act 2001 for the financial
year ended June 30, 2021.
The remuneration report has been audited as required by s308 (3C) of the Corporations Act.
Introductory Comments from Donal O’Dwyer, Nomination and Remuneration Committee Chairman
The 2021 financial year was an eventful one in terms of Company milestones with significant developments across all of the
Company’s programs, as well as on the partnering and financing fronts.
We are very aware that the market value of the company is lower now than it was at this time last year and the factors that have
led to this circumstance. The milestones have not all followed the roadmap as envisaged at this time last year. The FDA’s complete
response letter was contrary to expectations following a 9:1 positive recommendation from the Oncologic Drugs Advisory Committee
and recruitment in the COVID-19 acute respiratory distress syndrome trial was stopped following the third interim analysis by the
Data Safety and Monitoring Board.
While these outcomes were not as planned, the Mesoblast executive team responded quickly to adapt strategies so that
Mesoblast’s path to commercialization can progress. There was also progress made within the programs for the treatment of chronic
lower back pain due to degenerative disc disease and chronic heart failure, for which Phase 3 trials completed during the year with
encouraging results.
The combination of mixed outcomes balanced by levels of program execution that were above expectation are reflected in this
year’s remuneration outcomes, with an STI outcome of 65% and 60% of maximum for the CEO and CFO respectively, incorporating
committee exercise of negative discretion. On the LTI front, no vesting milestones were realized for this year for the KMP. Fixed
remuneration for our KMP has remained static year on year.
Last year we reported significant changes made to the remuneration framework by the Nomination and Remuneration
Committee, which remain in place. These changes were positively received by investors, who overwhelmingly voted for the
remuneration report resolution at the 2020 AGM (96.18%). The changes included:
• Decreasing the amount of annual cash that the CEO could earn through halving the STI opportunity from 100% of fixed
remuneration to a maximum of 50% of fixed remuneration (the STI represented 14% of total maximum remuneration
opportunity in FY21).
• Decreasing the weighting of the CEO’s fixed remuneration and increasing the weight of pay contingent on performance.
• Making long term incentives a major part of the CEO’s remuneration package. These consist of an option grant subject to
milestone performance conditions which must be achieved over 3 years. If achieved earlier, vesting is restricted so that it is
only by the third year that all options will have vested.
Requiring KMP and executive options to be subject to both milestone achievement and continued service before vesting.
•
• Describing the KMP LTI rationale and performance conditions with greater detail.
Not only have these changes resulted in lower cash costs, preserving our cash reserves for investing in research and
commercialization, but the change in remuneration mix towards long-term performance tested options better ensures that executive
outcomes are aligned to those of shareholders. The executives only receive the value from any milestone-based options that vest if
shareholders also realize increases in share price over the same period.
During the last year, in order to ensure our remuneration settings remained competitive, we commissioned an international
remuneration consultancy firm to help us rigorously and independently benchmark our executives on a role-by-role basis against an
industry peer group of US listed organizations (14 companies selected with consideration to organization size, region, industry and
clinical stage) and a peer group of listed ASX companies. Overall, the report supported the senior executive remuneration levels
across Mesoblast, with the settings being competitive on an overall remuneration basis across both the industry peer group and the
ASX peer group, although the LTI opportunities were at the lower end of the range for the industry peer group.
With respect to the CEO’s remuneration, the findings were similar to the other senior executives as it relates to fixed
remuneration and STI. However, the relativity of the CEO’s LTI opportunity to the industry group benchmark was not aligned to that
for the rest of the senior executive team, with the CEO’s LTI and total remuneration opportunity being significantly below market.
80
While we determined it prudent to remain below market, we increased the CEO’s maximum LTI opportunity at the end of FY20 from
40% to 58% of total remuneration to partially correct the imbalance. To conserve cash, no adjustments were made to fixed
remuneration or STI cash opportunity from their reduction in FY20 to permit a rebalance to the higher LTI opportunity. Our decision
was also consistent with the stated preference of our investors for long term at risk pay that is aligned to the increase in shareholder
wealth. This change was put to shareholders at the FY20 AGM for the CEO’s FY21 LTI grant, which was passed with 94.96%
support.
It is important to note when considering this change that:
The LTI options will have no value unless share price increases.
•
• Milestone-based LTI awards in life science sectors typically have a higher risk profile than those in the broader market, and
may not materialize to levels anticipated at grant.
As in FY20, the COVID-19 pandemic did not this year materially lead to a reduction in Mesoblast’s circumstances, nor require
Mesoblast to utilize government support. Mesoblast has actively implemented a COVID-19 program focused on employee safety and
has instituted various changes to working requirements to minimize threats to our employees arising from the pandemic. While there
has been some impact on our work schedule and efficiency the Board has deemed these to be minimal, such that there need be no
special consideration of incentive targets set for KMP executives.
In summary, we believe FY21 has shown that the Mesoblast framework is fit for purpose by appropriately remunerating
executives in the short term for consistent, timely, safe and efficient achievement of research objectives as well as strategic agility to
remain on the path to commercialization, and ensuring zero executive LTI value accrues unless shareholder value has increased. We
trust you will agree and support our remuneration framework and as always welcome your further feedback.
Donal O’Dwyer
Nomination and Remuneration Committee Chairman
81
6.A
Directors and Senior Management Personnel
Key Management Personnel (KMP)
Key management personnel (KMP), defined as individuals who have authority and responsibility for planning, directing and
controlling the activities of the company, directly or indirectly, and including all directors, are listed in Table 1.
Name
Position
Country
Portion of year served as
KMP
Table 1 – Mesoblast KMP during FY2021
Non-executive directors
Joseph Swedish
William Burns
Donal O’Dwyer
Michael Spooner
Independent Chairman, Board of Directors
Member, Audit and Risk Committee
US
Full Year
Independent Vice Chair, Board of
Directors
Member, Nomination and Remuneration
Committee
Independent Non-executive Director
Chair, Nomination and Remuneration
Committee
Member, Audit and Risk Committee
Independent Non-executive Director
Chair, Audit and Risk Committee
Member, Nomination and Remuneration
Committee
Switzerland
Full Year
Australia
Full Year
Australia
Full Year
Eric Rose
Independent Non-executive Director
Shawn Cline Tomasello
Independent Non-executive Director
Member, Nomination and Remuneration
Committee
Philip Facchina
Independent Non-executive Director
US
US
US
Full Year
Full Year
Since March 29, 2021
Executive director
Silviu Itescu
Other executive KMP
Chief Executive Officer
Executive Director
Australia
Full Year
Josh Muntner
Chief Financial Officer
US
Full Year
82
Details of Directors and Senior Management
Board of Directors
Joseph Swedish, MHA
Appointed as Chairman of the Board of Directors on April 1, 2019.
Experience and expertise
Joseph. R. Swedish has more than two decades of healthcare leadership experience as the CEO for major United States
healthcare enterprises. Most recently, he has served as Executive Chairman, President and CEO of Anthem Inc., America’s leading
health benefits provider. Prior to joining Anthem, Mr. Swedish was CEO for several major integrated healthcare delivery systems,
including Trinity Health and Colorado’s Centura Health. Currently, he sits on the board of directors of IBM Corporation, CDW
Corporation, and Centrexion Therapeutics. Mr. Swedish is a member and previously Chairman of Duke University’s Fuqua School of
Business Board of Visitors. Previously, he was Chairman of the Catholic Health Association and the America’s Health Insurance
Plans. Mr. Swedish received a bachelor’s degree from the University of North Carolina and his master’s degree in health
administration from Duke University.
Other current directorships of listed public companies
Non-Executive Director, IBM Corporation (since 2017)
Non-Executive Director, CDW Corporation (since 2015)
Former directorships of listed public companies within the last 3 years
Executive Chairman, Anthem, Inc. (2013 - 2018)
William Burns, BA
Non-Executive Member of the Board of Directors
Experience and expertise
Mr. Burns has served on our board of directors since 2014 and was appointed Vice Chairman in 2016. He spent his entire
management career at the Beecham Group and F. Hoffmann-La Roche Ltd. He was Chief Executive Officer of Roche Pharmaceuticals
from 2001 to 2009, when he joined the board of directors of F. Hoffmann-La Roche Ltd. until he retired in 2014. He is the Chair of
Molecular Partners, and has been a Non-Executive Director of Shire PLC, Chugai Pharmaceutical Co., Genentech, Crucell, and
Chairman of Biotie Therapies Corp. from 2014 until its sale to Acorda Therapeutics Inc. in 2016. Mr Burns is also a member of the
Oncology Advisory Board of the Universities of Cologne/Bonn in Germany. In 2014, he was appointed a trustee of the Institute of
Cancer Research, London, and from March 2016 until April 2020 a Governor of The Wellcome Trust in London, UK. His extensive
experience in the pharmaceutical industry, specifically as a member of the board of directors of other pharmaceutical companies,
provides pharmaceutical, healthcare, industry, leadership and management expertise.
Other current directorships of listed public companies
Chair of Molecular Partners (since 2018)
Former directorships of listed public companies within the last 3 years
Non-executive Director, Shire (UK) (2010 – 2018)
Philip Facchina
Appointed to the Board as a Non-Executive Director on March 29, 2021.
Experience and expertise
Mr. Facchina brings more than 35 years of experience in corporate strategy, capital markets, finance, and business development
across several industries, including healthcare. Since 2018, Mr. Facchina has been Chief Strategy Officer at SurgCenter Development,
the largest privately held operator of ambulatory surgery centers in the US, overseeing the company’s strategic relationships, including
its relationships with the broad US ASC market, certain hospital systems and other market constituents. Prior to SurgCenter, Mr.
Facchina spent two decades in the public and private capital markets, where he managed liquid and illiquid portfolios, and managed
public and private capital transactions of equity and debt, led M&A and special advisory processes including take-privates. From 2008
to 2017, Mr. Facchina served as a Partner, Co-Portfolio Manager and the Chief Operating Officer of Ramsey Asset Management, an
institutional investment management firm, and from 1998 to 2008 Mr. Facchina led the technology, media and communications and
healthcare investment banking groups of FBR Capital Markets. Mr. Facchina currently serves as an independent director for ViON
83
Corporation and Millennium Global Treasury Services, and is Advisor to the CEO of Johanna Foods Inc, where he heads the Audit
Committee and he also serves as an advisor to New Markets Venture Partners. Previously, among other directorships and committee
posts, Mr. Facchina served on the Board of Web.com, where he led Corporate Governance. Mr. Facchina is a qualified financial
expert for SEC and NASDAQ purposes.
Other current directorships of listed public companies
None
Former directorships of listed public companies within the last 3 years
Web.com (2010-2018)
Donal O’Dwyer, BE, MBA
Non-Executive Member of the Board of Directors
Experience and expertise
Mr. O’Dwyer has served on our board of directors since 2004. He has over 25 years of experience as a senior executive in the
global cardiovascular and medical devices industries. From 1996 to 2003, Mr. O’Dwyer worked for Cordis Cardiology, the cardiology
division of Johnson & Johnson’s Cordis Corporation, initially as its president (Europe) and from 2000 as its worldwide president.
Prior to joining Cordis, Mr. O’Dwyer worked with Baxter Healthcare, rising from plant manager in Ireland to president of the
Cardiovascular Group, Europe, now Edwards Lifesciences. Mr. O’Dwyer is a qualified civil engineer with an MBA. He is on the
board of directors of Fisher & Paykel Healthcare Ltd and NIB Holdings Ltd. He also served on the board of Cochlear Ltd for 15 years
and retired from their board in October 2020. With his experience as a senior executive and a director, as well as his extensive
experience in the cardiovascular and medical devices industries, Mr. O’Dwyer provides business, science, engineering and
management expertise.
Other current directorships of listed public companies
Non-executive Director, Fisher & Paykel Healthcare (since 2013)
Non-executive Director, NIB Holdings Ltd (since 2016)
Former directorships of listed public companies within the last 3 years
Non-executive Director, CardieX Ltd (formerly called Atcor Medical Holdings Ltd) (2004 – 2019)
Non-executive Director, Cochlear Ltd (2005 - 2020)
Eric Rose, MD
Non-Executive Member of the Board of Directors
Experience and expertise
Dr. Rose has served on our board of directors since 2013. From 2007 through 2021, Dr Rose was with SIGA Technologies
initially as CEO from 2007 to 2017 and then Chairman. From 2008 through 2012, Dr. Rose served as the Edmond A. Guggenheim
Professor and Chairman of the Department of Health Evidence and Policy at the Mount Sinai School of Medicine. From 1994 through
2007, Dr. Rose served as Chairman of the Department of Surgery and Surgeon-in-Chief of the Columbia Presbyterian Center of New
York Presbyterian Hospital. From 1982 through 1992, he led the Columbia Presbyterian heart transplantation program in the United
States. Dr. Rose currently sits on the board of directors of ABIOMED. His experience as a surgeon, researcher and businessman
provides medical, pharmaceutical, scientific and industry expertise.
Other current directorships of listed public companies
Non-executive Director, ABIOMED, Inc. (2007 – 2012, 2014 – present)
Former directorships of listed public companies within the last 3 years
Chairman, SIGA Technologies, Inc. (2017 - 2021)
84
Michael Spooner, BCom, ACA, MAICD
Non-Executive Member of the Board of Directors
Experience and expertise
Mr. Spooner has served on the Board of Directors since 2004. During this period he has filled various roles including as
Chairman from the date of the ASX public listing in 2004 until 2007. Over the past several years Mr. Spooner has served on the board
of directors in various capacities at several Australian and international biotechnology companies, including BiVacor Pty Ltd (2009-
2013), Advanced Surgical Design & Manufacture Limited (2010-2011), Peplin, Inc. (2004-2009), Hawaii Biotech, Inc. (2010-2012),
Hunter Immunology Limited (2007-2008), and Ventracor Limited (2001-2003). He has been the Chairman of Simavita Ltd since May
2016 and Chairman of MicrofluidX since February 2018. Prior to returning to Australia in 2001, Mr. Spooner spent much of his career
internationally where he served in various roles including as a partner to PA Consulting Group, a UK-based management consultancy,
and a Principal Partner and Director of Consulting Services with PricewaterhouseCoopers (Coopers & Lybrand) in Hong Kong. In
addition Mr Spooner has owned and operated several international companies providing services and has consulted to a number of
U.S. and Asian public companies. Mr. Spooner provides executive management, commercial, business strategy and accounting
expertise as well as established relationships with investment firms and business communities worldwide.
Other current directorships of listed public companies
Former directorships of listed public companies within the last 3 years
Chairman, Simavita Ltd (2016 - 2021)
Shawn Cline Tomasello, BS, MBA
Appointed to the Board as a Non-Executive Director on July 11, 2018.
Experience and expertise
With more than 30 years’ experience in the pharmaceutical and biotech industries, Shawn Cline Tomasello has substantial
commercial and transactional experience. Since 2015, Ms. Tomasello had been Chief Commercial Officer at leading immuno-
oncology cell therapy company Kite Pharma, where she played a pivotal role in the company’s acquisition in 2017 by Gilead Sciences
for $11.9 billion. Prior to this she served as Chief Commercial Officer at Pharmacyclics, Inc., which was acquired in 2015 by AbbVie,
Inc. for $21 billion. Ms. Tomasello previously was President of the Americas, Hematology and Oncology at Celgene Corporation
where she managed over $4 billion in product revenues, and was instrumental in various global expansion and acquisition strategies.
She has also held key positions at Genentech, Pfizer Laboratories, Miles Pharmaceuticals and Procter & Gamble. Ms. Tomasello
currently serves on the Board of Directors of Gamida Cell, Ltd. and UroGen Pharma, Ltd, TCR2 Therapeutics, and 4D Molecular
Therapeutics. She previously served on the board of Principia Biopharma; acquired by Sanofi, Abeona Therapeutics (resigned),
Clementia Pharmaceuticals, Inc. which was acquired by Ipsen, SA, and Diplomat Specialty which was acquired by United Healthcare.
She received a MBA from Murray State University and a B.S. in Marketing from the University of Cincinnati. Her extensive
experience in the pharmaceutical and biotech industries, particularly in the commercial and transactional fields, provides industry,
leadership and management expertise.
Other current directorships of listed public companies
Director, Gamida Cell, Ltd. (since 2019)
Director, UroGen Pharma, Ltd. (since 2019)
Director, TCR² Therapeutics Inc. (since 2021)
Director, 4D Molecular Therapeutics (since 2020)
Former directorships of listed public companies within the last 3 years
Director, Clementia Pharmaceuticals, Inc. which was acquired by Ipsen, SA. (2018 – 2019)
Non-Executive Director, Diplomat Pharmacy, Inc. (2015 – 2020)
Director, Abeona Therapeutics, Inc. (2020)
Director, Principia Biopharma, Inc. which was acquired by Sanofi (2019-2020)
85
Senior Management
Silviu Itescu, MBBS (Hons), FRACP, FACP, FACRA
Chief Executive Officer
Executive Member of the Board of Directors
Experience and expertise
Dr. Itescu is our Chief Executive Officer (“CEO”). He has served our board of directors since our founding in 2004, was
Executive Director from 2007 to 2011, and became CEO and Managing Director in 2011. Prior to founding Mesoblast in 2004,
Dr. Itescu established an international reputation as a physician scientist in the fields of stem cell biology, autoimmune diseases, organ
transplantation, and heart failure. He has been a faculty member of Columbia University in New York, and of Melbourne and Monash
universities in Australia. In 2011, Dr. Itescu was named BioSpectrum Asia Person of the Year. In 2013, he received the inaugural Key
Innovator Award from the Vatican’s Pontifical Council for Culture for his leadership in translational science and clinical medicine in
relation to adult stem cell therapy. Dr. Itescu has consulted for various international pharmaceutical companies, has been an adviser to
biotechnology and health care investor groups, and has served on the board of directors of several publicly listed life sciences
companies.
Other current directorships of listed public companies
None
Former directorships of listed public companies within the last 3 years
None
Josh Muntner, BFA, MBA
Resigned effective August 31, 2021
Chief Financial Officer
Mr. Muntner has accrued 20 years’ experience in healthcare investment banking and corporate finance, and has been involved in
a wide range of healthcare-related transactions with approximately $11.0 billion in value. Most recently, he led corporate development
and financial transactions at Nasdaq-listed biotechnology company, ContraFect Corporation. Previously, Mr. Muntner served as
Managing Director and Co-Head of Healthcare Investment Banking at Janney Montgomery Scott, and spent nine years at
Oppenheimer & Co. and its U.S. predecessor, CIBC World Markets. He also served as an investment banker at Prudential Securities.
Mr. Muntner has a BFA from Carnegie Mellon and a MBA from the Anderson School at UCLA.
Andrew Chaponnel, BCom, CAANZ
Chief Financial Officer (interim) – appointed effective August 31, 2021
Mr. Chaponnel has around 25 years of experience in finance roles including 9 years with Mesoblast, initially as the Group
Financial Controller (6 years) and for the past 3 years as Head of Finance. As part of Mesoblast Group finance leadership he has been
integral to the implementation and maintenance of our borrowing arrangements, various strategic partnerships, equity placements, the
NASDAQ IPO and leads both ASX and NASDAQ financial reporting. Previously Mr. Chaponnel has held several roles including
management roles in chartered accountancy, logistics, retail and a CFO role within construction before moving into Healthcare. He is
a member of the Chartered Accountants of Australia & New Zealand.
Fred Grossman D.O. FAPA
Chief Medical Officer
Dr. Grossman joined Mesoblast in August 2019 and leads the Medical Affairs, Drug Safety Clinical Operations and Biostatistics
teams. Dr Grossmann is a Board-Certified psychiatrist and Fellow of the American Psychiatric Association with over 30 years of
experience in research, academia, and practice. He has held executive positions leading and building clinical development, medical
affairs, and pharmacovigilance in large and small pharmaceutical companies including Eli Lilly, Johnson & Johnson, Bristol Myers
Squibb, Sunovion, Glenmark, and NeuroRx. Dr. Grossman has developed and supported the launch of numerous blockbuster
medications addressing significant unmet medical needs across multiple therapeutic areas including CNS, immunology, immuno-
oncolology, respiratory, cardiovascular/metabolics, and virology. He has close relationships with thought leaders worldwide and has
negotiated directly with the FDA and Global Health Authorities for approval of many drugs across therapeutic areas. He has numerous
publications and presentations and has held several academic appointments.
86
Peter Howard, BSc, LLB (Hons)
General Counsel
Mr. Howard has served as our General Counsel and Corporate Executive since July 2011. As external counsel and partner at
Australian law firm, Middletons (now, K&L Gates), Mr. Howard has been integrally involved with Mesoblast since its inception and
public listing on the ASX in 2004. More generally, Mr. Howard has extensive experience with many biopharmaceutical firms and
major research institutions, covering public listings, private financings, strategic, licensing, intellectual property and mergers and
acquisition activities. He has done so in several roles, including as a partner at a major law firm, entrepreneur, director and senior
executive.
John McMannis, PhD
Head of Manufacturing– Resigned during the reporting year but remains a consultant
Dr. McMannis served as our Head of Manufacturing since 2011. He has 27 years of experience in clinical cellular therapy trials
in both academic and commercial environments. Before joining Mesoblast, Dr. McMannis served at the University of Texas MD
Anderson Cancer Center as a Professor of Medicine from 1999 to 2011, and as the Director of the Cell Therapy Laboratory from 1999
to 2011, and as the Technical Director of the Cord Blood Bank from 2008 to 2011. Before his tenure at the University of Texas MD
Anderson Cancer Center, Dr. McMannis was a Senior Director Technical Affairs at the Immunotherapy Division of Baxter and
Therapy Scientist at COBE BCT (now Terumo BCT). Dr. McMannis has served on the scientific advisory boards at BioSafe SA,
Biolife Solutions, Inc., and General Electric and on the board of directors for the American Association of Blood Banks, or AABB,
and the National Marrow Donor Program, or NMDP, which operates the “Be the Match” donor program.
Justin Horst, BS
Head of Manufacturing
Justin Horst has 18 years of experience in clinical cell therapy manufacturing and industry development. During the past eight
years, he has been Mesoblast’s Deputy Head of Manufacturing, with accountability for chemistry, manufacturing and control of the
manufacturing processes. Before joining Mesoblast, Mr. Horst was at Lonza Walkersville Inc. for 10 years, holding numerous senior
level positions within the manufacturing, project management, and business development groups. At Lonza, he was instrumental in
the establishment of the contract manufacturing business, and managed multiple manufacturing teams supporting numerous custom
supply processes. Mr. Horst obtained his B.S. in Biology from Towson University in Maryland.
Dagmar Rosa-Bjorkeson, MS, MBA
Chief Operating Officer
Dagmar Rosa-Bjorkeson has more than 25 years of global experience in the pharmaceutical industry, including executive
leadership in corporate and product strategy, market development and operational execution. She has led multiple successful product
launches, including Gilenya® for multiple sclerosis and Elidel® for atopic eczema. During her 17 years at Novartis, Ms. Rosa-
Bjorkeson was Vice President and Head of its Multiple Sclerosis Business Unit; Vice President, Business Development and Licensing
in the United States; and Country Head and President for Novartis Sweden. More recently, she served as Executive Vice President and
President, Biosimilars, at Baxalta, now a wholly owned subsidiary of Takeda Pharmaceutical Company. Ms. Rosa-Bjorkeson was also
Executive Vice President and Chief Strategy and Development Officer at Mallinckrodt Pharmaceuticals. She holds an MBA in
Marketing, an MS in Chemistry and a BS, Chemistry from the University of Texas.
Michael Schuster, MBA
Pharma Partnering
Mr. Schuster, who joined Mesoblast in 2004, leads the Group's partnering discussions. Previously he was the head of the
Group's investor relations outreach program and was part of the founding executive team at both Mesoblast Limited and Angioblast
Systems, Inc. Mr. Schuster was Executive Vice President of Global Therapeutic Programs from 2010 to 2013 and was the Director of
Business Development and Vice President of Operations from 2004 to 2010. He holds an undergraduate degree in science from Tufts
University, a Master’s degree in Immunology & Microbiology from New York Medical College, and an MBA from Fordham
University in New York.
87
Paul Simmons, PhD
Head of Research and New Product Development
Dr. Simmons has served as our Head of Research and New Product Development since 2011. He has nearly 30 years of
experience in stem cell research, especially research in basic hematopoiesis and in precursor cells for the stromal system of the bone
marrow, and served as President of the International Society of Stem Cell Research, or ISSCR, from 2006 to 2007. Prior to joining
Mesoblast, Dr. Simmons held the C. Harold and Lorine G. Wallace Distinguished University Chair at the University of Texas Health
from 2008 to 2011 and served as the inaugural Professor and Director of the Centre for Stem Cell Research at the Brown Foundation
Institute of Molecular Medicine from 2006 to 2011. Dr. Simmons is, or has served as, an associate editor, a member of the editorial
board, or a reviewer on multiple scientific and medical journals including Experimental Hematology, Cytotherapy and Stem Cell
Research, Cell Stem Cell, Stem Reports, Science and Nature.
Geraldine Storton, BSc, MMS, MBA
Head of Regulatory Affairs and Quality Management
Ms. Storton is a seasoned pharmaceutical executive with more than 30 years’ experience across the full value chain of
Pharmaceutical and Medical Device Research and Development, production and commercialization worldwide. She has an extensive
background in regulatory affairs and quality, most recently as a consultant to cell therapy companies. Prior to this, Ms. Storton held
executive roles at Hospira, and its predecessor companies in both regulatory affairs and quality, with a focus on major program
management. As Vice President, Program Management, Quality, at Hospira headquarters in Chicago, she led a company-wide quality
remediation program to improve compliance in manufacturing across 15 facilities worldwide. As Regional Director, Commercial
Quality ANZ, Asia and Japan, Ms. Storton was responsible for quality oversight and management of all products sold in Asia Pacific
countries. Her responsibilities included regulatory compliance, batch release, field actions, complaints management, change control,
due diligence and new product launch. As director of global regulatory operations, Ms. Storton managed development and registration
of new products and on-market management of the existing product portfolio for all Hospira’s products developed or manufactured
within Asia Pacific for global distribution. She joined Mesoblast in December 2015.
There are no family relationships among any of our directors and senior management. The business address of each of our
directors and senior management is Mesoblast Limited, Level 38, 55 Collins Street, Melbourne, VIC 3000, Australia.
KMP Interests
The relevant interest of each KMP, as defined by section 608 of the Corporations Act, in the share capital of Mesoblast, as
notified by the directors to the ASX in accordance with section 205G(1) of the Corporations Act, at the date of this report is as
follows:
Table 2 – KMP Interests
Director
Silviu Itescu
Josh Muntner
William Burns
Donal O'Dwyer
Eric Rose
Michael Spooner
Joseph Swedish
Shawn Cline Tomasello
Philip Facchina(1)
Mesoblast Limited
ordinary shares
68,958,928
—
63,000
1,234,392
—
1,069,000
—
—
273,224
Options over
Mesoblast Limited
ordinary shares
3,085,334
1,000,000
220,000
100,000
220,000
100,000
500,000
200,000
—
(1)
The board approved a grant of 200,000 options for Philip Facchina on April 15, 2021, this grant is subject to shareholder
approval at the upcoming AGM. Mr Facchina also has a relevant interest in 68,306 warrants over ordinary shares.
88
Meeting of Directors
The number of meetings our board of directors (including committee meetings of directors) held during the year ended June 30,
2021 and the number of meetings attended by each director were:
Table 3 – Meeting of Directors
Board of Directors
B*
A*
24
25
21
25
25
25
24
25
23
25
24
25
23
25
6
6
Audit and Risk Committee
A
4
—
—
4
—
—
4
—
B
3
—
—
4
—
—
4
—
Nomination and
Remuneration Committee
A
—
6
—
6
—
6
6
—
B
—
6
—
6
—
5
6
—
Director
Joseph Swedish
William Burns
Silviu Itescu
Donal O'Dwyer
Eric Rose
Shawn Tomasello
Michael Spooner
Philip Facchina
A = Number of meetings held during the time the director held office or was a member of the committee.
B = Number of meetings attended by board/committee members
— = Not a member of the relevant committee
* = This includes both meetings scheduled in the board calendar as well as teleconference meetings organized on an ad-hoc basis.
Each director attended every scheduled meeting in the board calendar.
6.B
Compensation
KMP Remuneration Governance
The Board is responsible for Mesoblast’s remuneration strategy and approach. The Nomination and Remuneration Committee
advises the Board on remuneration and incentive policies and practices generally, and makes specific recommendations on
remuneration packages and other terms of employment for executive Directors, other senior executives and non-executive Directors.
The Nomination and Remuneration Committee is wholly comprised of independent members: Donal O’Dwyer (Chair), William
Burns, Michael Spooner and Shawn Tomasello. The board is satisfied that Donal O’Dwyer and Michael Spooner are independent
despite their long-standing tenure on the board and Mr. Spooner’s brief role as an executive Chairman following the company’s
incorporation.
The Nomination and Remuneration Committee is primarily responsible for making recommendations to the Board on:
•
•
•
•
•
•
Board appointments
Non-executive director fees
Executive remuneration framework
Remuneration for executive directors, namely the CEO, and other key executives
Short-term and long-term incentive awards
Share ownership plans
The Nomination and Remuneration Committee’s objective is to ensure remuneration policies are fair and competitive and have
regard for industry benchmarks whilst being aligned with the objectives of our company.
The Committee receives proposals from the executive team, which it critically reviews. When appropriate the Nomination and
Remuneration Committee will seek advice or recommendations from independent expert consultants, such as the benchmarking study
received during the year and referenced in the introductory comments to this report. Advice provided by consultants during the year
did not constitute a ‘remuneration recommendation’ as a defined in section 9B of the Corporations Act and was received free from any
undue influence by Key Management Personnel to whom the advice related.
89
Executive Remuneration Strategy
The Company’s remuneration strategy is designed to ensure Mesoblast can:
•
•
Attract and retain experienced leaders and emerging experts in an innovative field and on a global basis
Reward performance that will lead in the long term to improved patient outcomes and increased shareholder wealth.
Our team is small. Mesoblast has only 83 employees, 58% of whom are in the US, with the remainder in Australia, Singapore
and Switzerland. Retaining these employees, who often are at the top of their respective fields, is imperative in ensuring Mesoblast
can continue in a consistent manner to work towards what are difficult, complex and long-term goals.
Biopharmaceutical product development is a highly specialized and speculative undertaking and it involves a substantial degree
of risk. To achieve and maintain long term profitability, companies must successfully develop product candidates, obtain regulatory
approval, and manufacture, market and sell those products for which regulatory approval is obtained. If this occurs, revenues depend
on the size of markets in which product candidates receive approval, the ability to achieve and maintain sufficient market acceptance,
pricing, reimbursement from third-party payors, and adequate market share for our product candidates in those markets. Not all
companies succeed in these activities, and not all companies generate revenue from product sales that is significant enough to achieve
profitability.
To have a chance of success, it is imperative that executives
a)
b)
c)
d)
possess the specialized skills to understand the complex products being developed and the various regulatory requirements
imposed across the globe
apply high degrees of discipline to ensure research and trials are undertaken safely and effectively, to a rigorous standard
and schedule, within tight budget constraints
seek to deliver earlier, with lower costs, key, well-defined milestones critical to progressing Mesoblast technology
stay focused on the end goal of commercialization.
While it may be many years from initial research until milestones lead to profitable outcomes, this does not reduce the
importance of the milestones themselves. Without the interim milestone steps on the way to therapy commercialization, the extensive
safety and efficacy data required would not be sufficient and approval by global regulatory authorities would not be achievable. Time
and costs are an important component part in this process of research, testing and milestone achievement, as both have compounding
effects on shareholder value.
To address the above, Mesoblast’s remuneration framework comprises:
-
-
-
-
competitive fixed remuneration
annual incentives payments contingent on intensive research, approvals and trials being undertaken on time and budget
longer term milestone-based incentive payments
payment delivered, in part, as options, which conserves cash, aligns with shareholder interests, and focuses executives on
strategy, risk management, and execution that optimizes shareholder value.
Mesoblast generally sets cash-based STIs at a lower quantum than option-based LTIs to conserve cash flow, focus executives on
value creation, and align executives with shareholders.
The current average tenure of our executive team of 7 years suggests that the framework works well to attract and retain
appropriate executive leadership.
90
Executive Remuneration Framework
Further details on the Mesoblast Executive Remuneration Framework is provided in Table 4 – Executive Remuneration
Framework.
Strategic Rationale
Table 4 – Executive Remuneration Framework
Performance-based Remuneration
Fixed Pay
Attract and retain key personnel on
a global basis via competitive
remuneration.
Comply with regional statutory and
(e.g.,
customary
superannuation
Australia;
medical insurance in the US.)
benefits
in
partnering
Short-term Incentives
Focuses attention on key KPIs (in
areas such as clinical, financial
and
strategy,
manufacturing, commercial, or
organizational
and
development) under cost and time
constraints that will lead to long-
in patient
term
shareholder
outcomes
wealth.
improvement
structure
and
Long-term Incentives
Serves multi-pronged purpose:
- Aligns remuneration outcomes
shareholder wealth
with
creation.
- Provides a
framework
for
wealth creation by prioritizing
key objectives that are critical
for long-term profitability.
via
term
speed
employees
- Rewards
of
achievement, that can have
long
compounding
effects
- Retains
deferral
- Provides
if
for
milestones
share price,
increases
aligning with the shareholder
experience.
- Conserves cash.
- Enables risk management via
only
accumulate
value
in
Process
annually on market
Assessed
relativities
relevant markets
in
based on position accountabilities.
The Nomination and Remuneration
Committee
specific
recommendations to the board on
remuneration packages for senior
executives for approval.
makes
malus.
Nomination
and
The
Remuneration
Committee
assesses vesting for the LTI
milestones.
Paid annually for performance
against annual corporate and
individual KPIs. The Nomination
and Remuneration Committee sets
the CEO’s KPIs. These are used to
measure
company
the
performance, which determines
for other
the pool available
employees. Allocations from that
pool for senior management are
determined with
to
individual KPIs which have been
set by
the CEO. Resulting
outcomes are approved by the
Nomination and Remuneration
Committee.
reference
91
Eligibility
All employees
All employees hired on or before
March 31, 2021 are eligible for
consideration. Employees hired
during the year are recognized on
a pro-rata basis.
positions
All eligible participants who are
in
influence
achievement of our long- term
outcomes and, where required,
for attraction and retention.
to
Quantum of opportunity
Set according to each position’s
incumbent’s
accountabilities,
experience and qualifications, and
regional market relativities.
the
Set as a percentage of fixed pay.
Quantum generally lower than LTI
to conserve cash.
Set using a percentage of fixed
pay as a guideline.
Current CEO maximum STI: 50%
of Fixed Remuneration.
Current CFO maximum STI: 50%
of Fixed Remuneration.
Current CEO maximum LTI:
approximately 200% of fixed
remuneration.
As disclosed in the FY20 AGM,
the CEO grant was increased to
bridge some of the gap with
industry LTI practice while also
decreasing the weighting of the
CEO fixed remuneration and
STI. The grant received 94.96%
approval.
Current CFO maximum LTI:
100% of fixed remuneration
on
from
The actual grant value for the
CEO and CFO LTI may vary
year
this
year
proportion based on various
taken account
factors being
including:
- shareholder dilution
- internal relativities
- share price volatility
Delivered as
Cash
Performance and service
period
N/A
While the value may fluctuate
on a year-to-year basis,
the
guideline should stand on a long
term basis.
Options over ordinary shares in
Mesoblast Limited with a 7-year
expiry date. Option exercise
price will be based on the 5-day
VWAP to grant date.
Three years with provision for
earlier vesting limited to one
third per year to (a) encourage
speed of achievement, and (b)
defer material amounts for better
governance and (c) encourage
on
executive
achievements that have a longer
term
impact on shareholder
value.
focus
Cash
1 year
92
Discretion, malus and
clawback
N/A
Cessation of employment
The board has the authority to use
its discretion to amend individual
including
outcomes “in year”,
to any
down
payment.
to zero, prior
The
has
board
ultimate
discretion
determining
in
vesting outcomes. Until options
are exercised, the board may
also
in
situations where executives have
behaved
or
fraudulently
lapse options
(unvested and vested).
dishonestly
to
discretion
apply
No award will be made
employees who have
employment.
to
ceased
Unvested options are forfeited
unless
exercises
Board
discretion. Vested options can
be retained subject to being
exercised within 60 days of
cessation or other
timeframe
specified by the board.
Hedging
Oversight
The company’s share trading policy prohibits hedging via the company’s derivatives.
Individual outcomes are reviewed and approved first by the Nomination & Remuneration Committee and
then the Board.
Remuneration Mix
The target remuneration mix at maximum for the CEO and the CFO is described in Figure 1.
Figure 1 – KMP Remuneration Mix.
The actual grant value year-on-year may vary from the target remuneration mix depending on factors such as:
•
•
•
•
Dilution considerations
Internal relativities
Date of grant
Difficulty of milestones
93
Responses to frequent questions on the Mesoblast framework
The following table presents responses to common queries on the Mesoblast remuneration framework.
Table 5 – Executive Remuneration Framework
Why do you use milestone performance
measures for the STI and LTI?
Why does some of the long term incentive
award vest earlier than a three year period?
What is Mesoblast’s position on diversity?
Traditional financial metrics are not meaningful, nor can they be effectively used to
accurately reflect the performance of our company. What creates lasting shareholder
value are successful outcomes from research and development, entry into new
collaborations and achievement of other planned and well considered corporate
objectives. Success will only result in significant reward under the LTI if the market
values our achievements. If it does, our share price increases. The LTI options become
valuable. If not, the options have no intrinsic value. This combination of milestones and
payment in options work in tandem for a sober, fair payment for performance aligned
with shareholder returns. This is a standard biotechnology company practice.
Within biotechnology, basing long term incentives on achievement of performance
milestones is a tried and true measure of aligning pay with performance. The other
factor that is critical is time. While we allow three years for milestones, earlier is better,
because we will have achieved it using less cash expense than if achieved at the end of
3 years. Therefore, we have configured the plan to allow for early vesting for early
achievement, but only to a point. We still insist that even if all milestones are achieved
early, some options remain unvested for 3 years, to ensure that, if given a choice with a
limited budget, employees focus on those milestones most likely to deliver the most
value over the longer term, as well as encouraging employee retention. We believe that
this framework is innovative, and a great fit for the nature of our business. We
acknowledge it does not look and feel like a typical ASX-listed company LTI, and
therefore may not meet the standard guidelines applied by many, but we are not typical.
We are open to considering alternatively designed incentives that address the value
drivers of milestone achievement, time to achieve them, prioritization of milestones
with most value potential given limited resourcing, and impact on longer term share
price. But so far we have not found any quite as effective.
The Group values diversity and recognizes the benefits it can bring to the organization’s
ability to achieve its goals. Diversity can lead to a competitive advantage through
broadening the talent pool for recruitment of high quality employees, by encouraging
innovation and improving a corporation’s professionalism and reputation. Accordingly,
the Group is committed to promoting diversity within the organization and has adopted
a formal policy outlining the Group’s diversity objectives.
With respect to gender diversity, as at 30 June 2021, 54% of the Company’s employee
base were female and 30% of the Company’s senior executives were female. The
Board is conscious of the gender imbalance at board level (with only one of the seven
non-executive directors being female) and has an objective to increase this number as
vacancies arise and circumstances permit.
Why is there no STI deferral?
STI is not a heavily weighted part of the remuneration framework across the Company.
There is sufficient remuneration deferred already, in the form of unvested options, that
would be at risk in the event of poor conduct, mismanagement or reputational damage.
Why is there no consideration of ENS
(Environment and Sustainability) issues in
the STI or LTI vesting considerations?
to
treat serious and
Mesoblast’s mission to bring to market innovative medicines comprised of naturally-
occurring cellular materials
is
fundamentally consistent with ENS principles, although there are relevant supply chain
and carbon footprint considerations. At this stage, Mesoblast’s physical footprint is
limited to office and laboratory space for its employee base of less than 100, so while
management is actively engaged in reducing the Company’s carbon footprint, its ability
to materially improve its ENS impact is currently limited. We will continue to consider
having ENS-related remuneration milestones in the future, in particular if and when
Mesoblast has its own manufacturing facilities and approved products.
life-threatening
illnesses
94
Mesoblast performance during FY2021
Table 6 provides share price performance data and selected financial results.
Table 6 – Company share price performance and selected financial results over the last five years
Currency
2021
2020
2019
2018
2017
Share price (ASX:MSB)
– closing at June 30
– high for the year
– low for the year
Market capitalization at June 30 (millions)
– increase/(decrease) – (millions)
– increase/(decrease) – as %
Revenue (millions)
- increase/(decrease) - as %
Loss before income tax (millions)
Net Assets (millions)
A$
A$
A$
A$
A$
US$
US$
US$
1.98
5.50
1.72
1,285
(613)
(32%)
7.5
(77%)
99.6
581.4
3.25
4.45
1.02
1,898
1,160
157%
32.2
92%
87.4
549.3
1.48
2.34
1.04
738
24
3%
16.7
(4%)
98.8
481.1
1.48
2.36
1.19
714
(177)
(20%)
17.3
619%
66.0
546.0
2.08
3.44
1.03
891
479
116%
2.4
(94%)
90.2
516.8
FY2021 has been an extremely busy year for Mesoblast. The team has reached important corporate and clinical outcomes across
Mesoblast’s major programs including:
-
-
-
-
-
-
-
Successful completion of US$110 million private placement, with cash balance at June 30, 2021, of US$136.9 million.
Private placement was led by US investor group SurgCenter Development (SurgCenter), one of the largest private operators
of ambulatory surgical centers (ASC) in the US specializing in spine, orthopaedic and total joint procedures.
Appointment of Philip J. Facchina, Chief Strategy Officer of SurgCenter, to the Mesoblast Board of Directors
Responding to the receipt of the United States Food & Drug Administration (FDA) Complete Response Letter last October
via discussions with the United States Food & Drug Administration (FDA). These have occurred through a well-established
regulatory process that may include a resubmission with a six-month review with the aim of achieving approval of
remestemcel-L in the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children.
Collating, analysing, finalising and releasing results from the randomized controlled trial of remestemcel-L in 222
ventilator-dependent COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS). These showed
that patients who received remestemcel-L had a reduced mortality through 60 and 90 days in the pre-specified population
under 65 years old.
Collating, analysing, finalising and releasing results from the trial of rexlemestrocel-L (MPC-06-ID) in 404 patients with
chronic low back pain (CLBP) due to degenerative disc disease (DDD). These showed that a single injection of
rexlemestrocel-L + hyaluronic acid (HA) carrier may provide at least two years of pain reduction, with opioid sparing
activity in patients using opioids at baseline.
Collating, analysing, finalising and releasing results from the Phase 3 trial of rexlemestrocel-L (REVASCOR®) in 537
patients with chronic heart failure (CHF) with reduced left ventricular ejection fraction (HFrEF), which showed that a
single dose of rexlemestrocel-L resulted in substantial reductions in heart attacks and strokes across the entire evaluable
study population of NYHA class II and III patients and a significant and durable reduction in cardiac death in patients with
New York Heart Association (NYHA) class II disease.
Commencement of an investigator-led randomized, controlled study of remestemcel-L delivered by an endoscope directly
to the areas of inflammation and tissue injury in up to 48 patients with medically refractory Crohn’s disease or ulcerative
colitis.
- Mesoblast has entered into a license and collaboration agreement with Novartis for the development, manufacture, and
commercialization of remestemcel-L, with an initial focus on the treatment of acute respiratory distress syndrome (ARDS),
including that associated with COVID-19. The agreement remains subject to certain closing conditions, including time to
analyze the results from the COVID-19 ARDS trial.
95
Remuneration outcomes for the year ended June 30, 2021
Fixed remuneration
The CEO and CFO’s fixed remuneration did not change from FY2020 to FY2021. The CEO’s fixed remuneration has not
changed since 2015.
STI
As announced last year, the quantum of the CEO’s STI opportunity reduced by 50% from FY2019 to FY2020 due to the
introduction of an LTI into the CEO’s remuneration mix in response to investor feedback. This has reduced the cash cost of the CEO’s
total remuneration by 40%.
The CEO’s STI objectives and outcomes for FY21 incorporating committee discretion are described in Table 7, resulting in an
STI outcome of 65% of maximum for the CEO. The CFO’s STI outcome was 60% of maximum.
Table 7 - Performance against FY2021 STI KPIs
KPI Category
KPI
Execute on Major Clinical Programs
Maximum
as % of
total STI
Rating Outcome as
% of total
STI
Significant progress has been made on our major clinical programs during this year with major Phase 3 readouts and FDA
interactions. The Board acknowledges that not all the clinical and regulatory outcomes across the programs were as planned,
but management’s prompt response to these outcomes and adaptation and execution of strategies to enable the continued
progress each program was considered commendable. The Board assessed that this objective was partially achieved.
Total for Major
Clinical Programs
Remestemcel-L
-Acute GVHD
• Post CRL outcome, execute FDA strategy for accelerated
approval in pediatric acute GVHD through Type A meeting
and dispute resolution process.
Remestemcel-L
-COVID 19 ARDS
• Completion of Phase 3 trial enrolment and readout.
• Progress in regulatory pathway through meeting with FDA.
• Manufacturing process developments.
Chronic Heart
Failure (CHF) and
Chronic Lower
Back Pain (CLBP)
• Progress in regulatory pathway through meeting with FDA.
• Manufacturing process developments.
Execute on Financing and Partnering Strategy
70%
70%
49%
(15%)
(30%)
(25%)
There have been substantial achievements during the year in this category. A partnership was signed with a large
pharmaceutical company, but at the time of this report it has yet to close. Accordingly, the Board has decided that this outcome
was only partially met for this year’s STI outcome. Additionally, a well-executed private placement ensured the Group was
well funded and able to continue its important development and commercialization work. This placement was completed at a
minimal discount to the market price. The Board assessed this objective was completely achieved.
Partnering
• Execution of a major partnering transaction achieved through the
20%
30%
6%
Finance
strategic partnership with a large pharmaceutical company.
• Successfully raised US$110 million of capital to fund ongoing
operations in March 2021 with minimal discount to prevailing
share price at the time.
• Successfully deferred principal repayment terms on our existing
structure debt arrangements as a result of achieving key
commercial milestones.
10%
100%
10%
96
This results in an overall STI outcome of 65% of maximum, such that the CEO has forfeited 35% of his total incentive opportunity.
LTI
Two conditions must be met for milestone options to vest.
•
•
The milestone for that option must be met
Achievement must be within the performance period
No LTI option tranches became eligible to vest during FY21 for the CEO. The vesting of the CEO’s LTI is based on meeting
clinical and commercialization milestones, as well as completion of licensing or collaboration agreements to build shareholder value.
The FDA’s approval of remestemcel-L was targeted for September FY21. Since this did not occur, this tranche did not become
eligible to vest and will not unless approval is achieved within the three-year period.
Details on the LTI options that could have vested based on FY21 performance and have vested based on prior year performance
are summarized in Table 8, along with the financial year in which those options will vest after milestones have been met.
Where an LTI milestone remains commercial in confidence it has been described in general terms. Many milestones also have
an associated delivery window and/or budget which are taken into account when determining if it was achieved. Some clinical
outcomes can be partially met depending on the quality and/or cost of results or extent of patient participation.
Table 8 – LTI Outcomes of July 2019 and 2020 grants
Number of
options
granted/Date
granted
Milestone
CEO 1,200,000
Nov 2020(1)
• Clinical/Commercialisation milestones related
to clinical and commercialization progress
across the Company’s lead programs.
• Completion of a significant
licensing/collaboration agreement to build
shareholder value and other confidential
financing objectives.
• Manufacturing milestones related to process
development.
Portion of
grant
attributed to
milestone
Status
40%
Pending
FY in which the
tranche will vest
based on time-
based vesting
conditions (1)
Pending
40%
Pending
Pending
20%
Pending
Pending
1,346,667(2)
Nov 2019
• Granting of a PDUFA date for remestemcel-L(4).
50%
Achieved
during FY20
FY21- 66.7%
FY22- 33.3%
• US FDA approval of remestemcel-L(3).
50%
Pending
Pending
CFO
350,000
July 2020
• Support and implementation of licensing deal
with a large pharmaceutical company.
33.3%
Pending
Pending
• Completion of corporate financing transaction
of material value.
• Prepare and execute fund raising transactions
including equity, debt and other financing
transactions.
33.3%
Pending
Pending
33.3%
Pending
Pending
97
500,000
July 2019
• Completion of capital raisings
(September 2019, May 2020).
• Support and implementation of Grünenthal
licensing deal (September 2019).
• Execute key value accretive business
development transactions.
40%
40%
Achieved
during FY20
Achieved
during FY20
FY21 – 41.7%
FY22 – 41.7%
FY23 – 16.6%
FY21 – 41.7%
FY22 – 41.7%
FY23 – 16.6%
20%
Pending
Pending
(1)
(2)
This grant was approved by the Board on July 16, 2020 and granted on November 24, 2020 after shareholder approval for the
grant was received at the AGM.
This grant was approved by the Board on July 20, 2019 and granted on November 27, 2019 after shareholder approval for the
grant was received at the AGM. 538,667 of the options granted were not milestone based and have not been included in the
above table. The 538,667 options were granted as a substitute for a reduction made to the FY2019 short-term cash bonus to
conserve cash.
(3)
For the treatment of pediatric SR acute GVHD.
Table 9 represents remuneration paid to each executive KMP during the year as required by Section 300A of the Corporations
Act 2001.
Table 9 – Statutory remuneration paid to executive KMP
Short-term benefits
Short-
term
cash
bonus(1)
$
Annual
Leave/
Holiday
Pay
$
Health
and
Other
Benefits
(2)
Post-
employment
benefits
Super-
annuation
Non-
monetary
benefits
$
$
$
Long-
term
benefits
Long
service
leave
$
Base
salary
Name
$
Silviu Itescu - Executive Director
Year Currency
Share-
based
payments
Options(3)
$
Other
Termi-
nation
benefits
$
Total
Statutory
Remuneration
$
% of
performance-
based
remuneration
%
2021 A$
2020 A$
1,010,000 328,250 77,687
1,010,000 555,500 69,931
—
—
—
—
21,694 16,880 1,207,365 —
21,003 16,926 978,232 —
2,661,876
2,651,592
Josh Muntner - Executive KMP
2021 A$(4)
2020 A$(4)
2021 US$
2020 US$
509,877 213,255 7,842
568,876 306,652 18,245
382,000 159,771 5,875
382,000 205,917 12,252
— 47,192
— 41,066
— 35,356
— 27,576
—
—
—
—
— 404,296 —
— 339,301 —
— 302,898 —
— 227,840 —
1,182,462
1,274,140
885,900
855,585
58%
58%
52%
51%
52%
51%
(1)
(2)
(3)
(4)
In FY2021, the CFO bonus amount includes a deferred sign-on payment of US$45,171 in addition to an amount of US$114,600
awarded for achieving 60% of his STI target. In FY2020, the CFO bonus amount includes a deferred sign-on payment of
US$24,467 in addition to an amount of US$181,450 awarded for achieving 95% of his STI target.
Includes health, dental, vision, life, long and short-term disability insurances.
The CEO’s share based payment includes amounts related to options approved at the November 2019 AGM. The amounts
included are A$280,418 and A$197,446 for FY2020 and FY2021, respectively.
The A$ results have been determined by calculating the average rate of the exchange rates on the last trading day of each month
during the period. A US$:A$ exchange rate of 1:0.7492 has been used for the year ended June 30, 2021 and 1:0.6715 for the
year ended June 30, 2020.
98
Non-Executive Director (“NED”) Remuneration
As at June 30, 2021 the Board comprised of seven NEDs; two based in Australia, four in the United States and one in
Switzerland. These directors are global experts in the biopharmaceutical industry and capital markets, each with relevant experience in
biotechnology and/or healthcare industries.
The NED fees (in Table 10) reflect responsibilities and work involved with directing a company of Mesoblast’s technological
and geographical complexity, our financial position, regulatory and compliance context, and market practice in each director’s
domicile. The fee levels and structures reflect what is necessary to recruit and retain directors with global experience in this industry.
There have been no changes to NED fees from last year.
Table 10 – NED fees
(exclusive of superannuation where applicable for Australian directors)
Position
Chair
Chair
Vice Chair
Member
As at June 30, 2021
Audit and
Risk
Committee
—
20,000
—
10,000
Board of
Directors
250,000
—
175,000
128,250
Nomination
and
Remuneration
Committee
—
20,000
—
10,000
Currency
US$
A$
A$
A$
The NEDs’ fixed fees for their services are not to exceed a maximum fee pool of A$1,500,000, as approved by shareholders at
the 2018 Annual General Meeting.
NEDs do not receive performance-related remuneration and are not provided with retirement benefits other than statutory
superannuation. NEDs are reimbursed for costs directly related to conducting Mesoblast business. The key terms of NED service are
documented in a letter of appointment to the Board.
Mesoblast grants options to directors, usually at the start of their tenure. Options in lieu of cash are typical in the biotechnology
industry. These options vest one third each after one, two and three years. The options are only able to be forfeited by the director if
they engage in conduct that is adverse to the company or breach the terms of their engagement.
The grants enable Mesoblast to secure directors with global pharmaceutical experience cash-effectively. Governance is not
compromised because no performance or service conditions apply. The majority of shareholders voted in favor of the grants made
during FY20 at the AGM in November 2019. There were no grants made during FY21, however the Board did approve an initial
grant of 200,000 options to Philip Facchina. These options were approved by the Board on April 15th, 2021 are subject to shareholder
approval at the 2021 AGM and are consistent with the grants made to other recently appointed directors.
Further detail on the number of options and exercise price can be found in section “Terms and conditions of share-based
payment arrangements”.
99
Remuneration Details - NEDs
Details of the remuneration of our NEDs for the years ended June 30, 2021 and June 30, 2020 are in Table 11.
Table 11 – Director Fees
Name
Joseph Swedish
Joseph Swedish
William Burns
William Burns
Donal O’Dwyer
Donal O’Dwyer
Eric Rose
Eric Rose
Michael Spooner
Michael Spooner
Shawn Tomasello
Shawn Tomasello
Philip Facchina(1)
Total non-executive directors
Total non-executive directors
Total non-executive directors (2)
Total non-executive directors (2)
Currency
A$
A$
A$
A$
A$
A$
A$
A$
A$
A$
A$
A$
A$
A$
A$
US$
US$
Base
Salary
334,876
370,706
185,000
185,000
158,250
158,250
128,250
128,250
158,250
158,250
136,583
128,250
32,063
1,133,272
1,128,706
849,047
757,926
Super-
annuation
Share-
based
payments
Options
—
—
—
—
15,034
15,034
—
—
15,034
15,034
—
—
—
30,068
30,068
22,527
20,191
75,224
175,571
50,327
62,495
9,921
23,241
50,327
62,495
9,921
23,241
17,595
43,489
22,087
235,402
390,532
176,363
262,242
Total
Statutory
Remuneration
410,100
546,277
235,327
247,495
183,205
196,525
178,577
190,745
183,205
196,525
154,178
171,739
54,150
1,398,742
1,549,306
1,047,938
1,040,359
Year
2021
2020
2021
2020
2021
2020
2021
2020
2021
2020
2021
2020
2021
2021
2020
2021
2020
(1)
(2)
Philip Facchina base salary is for a part year as he was appointed March 29, 2021.
The A$ results have been determined by calculating the average rate of the exchange rates on the last trading day of each month
during the period. A US$:A$ exchange rate of 1:0.7492 has been used for the year ended June 30, 2021 and 1:0.6715 for the
year ended June 30, 2020.
100
Terms and conditions of option grants and equity holdings
Details of options over ordinary shares provided as remuneration to each director and member of key management personnel for
the years ended June 30, 2021 and June 30, 2020 are provided in the tables below.
Table 12 – The value of options granted, exercised and lapsed.
Number of
options
granted
Remuneration
consisting of
options (1)
Values of options
granted (2)
A$
Value of options
exercised (3)
A$
Value of options
lapsed (4)
A$
For the year ended June 30, 2021
Silviu Itescu
Joseph Swedish
William Burns
Donal O’Dwyer
Eric Rose
Michael Spooner
Shawn Tomasello
Philip Facchina(5)
Josh Muntner
For the year ended June 30, 2020
Silviu Itescu
Joseph Swedish
William Burns
Donal O’Dwyer
Eric Rose
Michael Spooner
Shawn Tomasello
Josh Muntner
1,200,000
—
—
—
—
—
—
—
350,000
1,885,334
—
100,000
—
100,000
—
—
500,000
46%
18%
21%
5%
28%
5%
11%
41%
35%
37%
32%
25%
12%
33%
12%
25%
27%
1,104,000
—
—
—
—
—
—
—
322,000
1,950,001
—
93,500
—
93,500
—
—
544,650
—
—
—
—
—
—
—
—
533,664
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
(1)
(2)
(3)
(4)
(5)
The percentage of the value of remuneration consisting of options, based on the value of options expensed during the year
presented in accordance with IFRS 2 Share-based Payment. For details on the assumptions made for each grant, see information
in note 17 Share-based payments within Item 18 Financial Statements of this report.
The accounting value at acceptance date of options that were granted during the year presented as part of remuneration,
determined using Black-Scholes valuation model and in accordance with IFRS 2 Share-based Payment. The acceptance date is
the date at which the entity and the employee agree to a share-based payment arrangement, being when the entity and the
employee have a shared understanding of the terms and conditions of the arrangement.
The intrinsic value at exercise date of options that were exercised during the year presented, having been granted as part of
remuneration previously.
The intrinsic value at lapse date of options that lapsed during the year.
The board approved a grant of 200,000 options for Philip Facchina on April 15, 2021, this grant is subject to shareholder
approval at the upcoming AGM. Mr Facchina also has a relevant interest in 68,306 warrants over ordinary shares.
There have been no modifications to any terms and conditions of share-based payment transactions during the years ended June
30, 2021 and 2020.
101
Reconciliation of Options held by KMP
The table below shows a reconciliation of options held by each KMP from the beginning to the end of FY2021.
Table 13 – Reconciliation of options held by each KMP during FY2021.
Balance at July 1, 2020
Granted
during
FY2021
Vested during
FY2021
Exercised
during FY2021
Forfeited /
Lapsed during
FY2021
Name
Grant Date
Vested Unvested Number Number % Number % Number %
24-Nov-20(1)
Silviu Itescu
—
27-Nov-19(2)
Silviu Itescu
—
Josh Muntner
—
16-Jul-20
Josh Muntner
—
20-Jul-19
Josh Muntner
100,000
15-Jul-18
William Burns
27-Nov-19
—
William Burns
30-Nov-18 40,000
Donal O'Dwyer
30-Nov-18 33,333
Eric Rose
27-Nov-19 40,000
Eric Rose
17-Nov-19
—
Michael Spooner
30-Nov-18 33,333
Joseph Swedish
27-Nov-19 100,000
30-Nov-18 133,334
Joseph Swedish
Shawn Tomasello 30-Nov-18 66,667
Philip Facchina(3)
—
—
—
1,885,334
—
500,000
200,000
100,000
80,000
66,667
80,000
100,000
66,667
200,000
66,666
133,333
—
1,200,000
—
350,000
—
—
—
—
—
—
—
—
—
—
—
—
—
628,445
—
166,667
100,000
33,333
40,000
33,333
40,000
33,333
33,333
100,000
66,666
66,667
—
—
33
—
33
33
33
33
33
33
33
33
33
33
33
—
—
—
—
—
150,000
—
—
—
—
—
—
—
—
—
—
—
—
—
—
50
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Unvested
Balance at June 30, 2021
Vested and
exercisable
—
628,445
—
166,667
50,000
33,333
80,000
66,666
80,000
33,333
66,666
200,000
200,000
133,334
—
1,200,000
1,256,889
350,000
333,333
100,000
66,667
40,000
33,334
40,000
66,667
33,334
100,000
—
66,666
—
(1) This grant was approved by the Board on July 16, 2020 and granted on November 24, 2020 after shareholder approval for the
grant was received at the AGM.
(2) This grant was approved by the Board on July 20, 2019 and granted on November 27, 2019 after shareholder approval for the
grant was received at the AGM.
(3) The board approved a grant of 200,000 options for Philip Facchina on April 15, 2021, this grant is subject to shareholder
approval at the upcoming AGM.
102
Terms and conditions of share-based payment arrangements
The terms and conditions of each grant of options affecting remuneration in the current or a future reporting period are as
follows:
Table 14 – Terms and conditions of share-based payment arrangements
Exercise price
A$
Value per
option at
acceptance date
A$
3.41
0.92(3)
Expiry date
15-Jul-27
15-Jul-27
3.41
0.92(3)
19-Jul-26
1.47
1.03
19-Jul-26
1.47
1.03
17-Nov-26
1.83
0.94
3-Apr-26
1.48
0.78
19-Jul-26
1.47
1.09(4)
29-Nov-25
1.33
0.54
17-Jun-25
1.52
0.85
10-Jul-25
1.56
0.78
14-Jul-25
1.72
0.58(5)
Grant date
24-Nov-20(1)
Recipients of Grants
Silviu Itescu
16/07/2020
Josh Muntner
27-Nov-19(2)
Silviu Itescu
27-Nov-19(2)
Silviu Itescu
27-Nov-19
William Burns
Eric Rose
27-Nov-19
Joseph Swedish
20-Jul-19
Josh Muntner
30-Nov-18
30-Nov-18
William Burns
Eric Rose
Michael Spooner
Donal O'Dwyer
Joseph Swedish
30-Nov-18
Shawn Tomasello
15-Jul-18
Josh Muntner
Vesting date
Vesting in accordance
with the following
schedule, but only after
achievement of
performance milestones:
one third - 16-Jul-2021
one third - 16-Jul-2022
one third - 16-Jul-2023
Vesting in accordance
with the following
schedule, but only after
achievement of
performance milestones:
one third - 16-Jul-2021
one third - 16-Jul-2022
one third - 16-Jul-2023
Vesting in accordance
with the following
schedule, but only after
achievement of
performance milestones:
one third - 19-Jul-2020
one third - 19-Jul-2021
one third - 19-Jul-2022
one third - 19-Jul-2020
one third - 19-Jul-2021
one third - 19-Jul-2022
one third - 17-Nov-2020
one third - 17-Nov-2021
one third - 17-Nov-2022
one third - 4-Apr-2020
one third - 4-Apr-2021
one third - 4-Apr-2022
Vesting in accordance
with the following
schedule, but only after
achievement of
performance milestones:
one third - 19-Jul-2020
one third - 19-Jul-2021
one third - 19-Jul-2022
one third - 30-Nov-2019
one third - 30-Nov-2020
one third - 30-Nov-2021
one third - 18-Jun-2019
one third - 18-Jun-2020
one third - 18-Jun-2021
one third - 11-Jul-2019
one third - 11-Jul-2020
one third - 11-Jul-2021
one third - 15-Jul-2019
one third - 15-Jul-2020
one third - 15-Jul-2021
103
25-Nov-14
William Burns
Eric Rose
one third - 25-Nov-2015
one third - 25-Nov-2016
one third - 25-Nov-2017
24-Nov-19
4.00
1.30
(1) This grant was approved by the Board on July 16, 2020 and granted on November 24, 2020 after shareholder approval for the
grant was received at the AGM.
(2) This grant was approved by the Board on July 20, 2019 and granted on November 27, 2019 after shareholder approval for the
grant was received at the AGM.
(3) The acceptance date on which these options have been valued is July 5, 2021.
(4) The acceptance date on which these options have been valued is December 17, 2019.
(5) The acceptance date on which these options have been valued is January 17, 2019.
Table 15 - Shares provided to KMPs on the exercise of remuneration options
No. of
options
exercised
during the
period
No. of
ordinary
shares in
Mesoblast
Limited
issued
Value per
share at
exercise date
A$
Exercise
price per
option
A$
Exercise Date
150,000
150,000
31-Aug-20
—
—
—
5.28
—
1.72
—
For the year ended June 30, 2021
Josh Muntner
For the year ended June 30, 2020
Nil
Options Granted as Remuneration
The following table presents options that have been granted over unissued shares during or since the end of the year ended June
30, 2021, to our Directors and our next 5 most highly remunerated officers.
Table 16 – Options Granted as Remuneration
Name
Directors
Silviu Itescu
Non-Directors
Fred Grossman
Peter Howard
Dagmar Rose-Bjorkeson(2)
Michael Schuster
Geraldine Storton
Issue Date
Exercise
Price
A$
Number of
shares, under
option
24-Nov-20(1)
3.41
1,200,000
16-Jul-20
16-Jul-20
—
16-Jul-20
16-Jul-20
3.41
3.41
—
3.41
3.41
615,000
350,000
—
400,000
350,000
(1) This grant was approved by the Board on July 16, 2020 and granted on November 24, 2020 after shareholder approval for the
grant was received at the AGM.
(2) Dagmar Rose-Bjorkeson did not receive an option grant on July 16, 2020 as she had recently received a sign on related option
grant in May 2020.
104
KMP Shareholdings
The table below shows a reconciliation of ordinary shares held by each KMP from the beginning to the end of the 2021 financial
year.
Table 17 – KMP Shareholdings
Balance at the start
of the year
Received during the
year upon exercise
of options
Acquisitions/
(Disposals) during
the year
Balance at the end
of the year
68,958,928
—
—
63,000
1,234,392
—
1,091,335
—
—
—
150,000
—
—
—
—
—
—
—
—
(150,000)
—
—
—
—
—
—
273,224
68,958,928
—
—
63,000
1,234,392
—
1,091,335
—
273,224
Name
Silviu Itescu
Josh Muntner
Joseph Swedish
William Burns
Donal O'Dwyer
Eric Rose
Michael Spooner(1)
Shawn Tomasello
Philip Facchina
(1)
This total includes shareholdings of related parties, of this balance, Mr. Spooner has a relevant interest, as defined under the
Corporations Act, of 1,069,000 ordinary shares.
Employment Agreements
The employment of our CEO and CFO are formalized in employment agreements, the key terms of which are as follows:
Name
Silviu Itescu (CEO)
Josh Muntner (CFO)
Table 18 – KMP Employment Agreements
Term
Notice period
Termination benefit
Initial term of 3 years
commencing April 1, 2014, and
continuing subject to a 12 month
notice period.
An ongoing employment
agreement until notice is given
by either party.
12 months
12 months base salary
1 month
12 months base salary
On termination of employment our CEO, who is based in Australia, is entitled to receive his statutory entitlements of accrued
annual and long service leave, together with any superannuation benefits.
On termination of employment our CFO, who is based in the United States, is entitled to participate in the Company’s
healthcare plan during the severance period.
There is no entitlement to a termination payment in the event of resignation (except, in the case of the CFO, if the Company has
materially reduced his role or benefits or materially moved office location) or removal for misconduct.
KMP Loans or related transactions
There were no loans or related transactions with KMP during the financial year.
105
Employee Profile
As of June 30, 2021, we had 83 (2020:102) employees globally:
Employees by Education
Employees by Experience
2
12
3
23
39
14
8
29
19
13
Bachelor Masters MD
PHD
Certificate
Big Pharma
Speciality Pharma
Corporate/Professional
Academia
Other
Employees by Gender
Employees by Region
38
45
1
25
9
48
Female Male
Australia
Singapore
USA
Switzerland
58% of our employees and a majority of our executives are based in the United States where Mesoblast operational activities are
concentrated.
Australia is corporate headquarters where 30% of the employees work. This includes the CEO and a portion of the executive
team. The remaining 11% of employees are located in Singapore and 1% in Switzerland where research and development activities are
primarily conducted.
(End of Remuneration Report)
106
Australian Disclosure Requirements
Shares under option
Unissued ordinary shares of Mesoblast Limited under option at the date of this Directors’ report are as follows:
Grant date
10/07/2015
26/08/2015
27/04/2016
31/10/2016
18/07/2020
6/12/2016
6/12/2016
16/09/2017
16/09/2017
13/10/2017
13/10/2017
24/11/2017
24/11/2017
18/06/2018
11/07/2018
18/07/2018
18/07/2018
15/07/2018
30/11/2018
19/01/2019
19/01/2019
4/04/2019
20/07/2019
20/07/2019
20/07/2019
20/07/2019
20/07/2019
20/07/2019
29/08/2019
29/08/2019
29/08/2019
25/11/2019
29/05/2019
18/11/2019
25/11/2019
25/11/2019
24/01/2020
17/04/2020
18/05/2020
18/05/2020
16/07/2020
16/07/2020
16/07/2020
16/07/2020
16/07/2020
16/07/2020
26/08/2020
11/09/2020
8/10/2020
20/11/2020
20/11/2020
17/02/2021
30/06/2021
Grand Total
Exercise price of options
A$
Expiry date of options
Number of shares under
option
30/06/2022
16/08/2022
6/03/2023
6/03/2023
30/06/2022
5/12/2023
5/12/2023
15/09/2024
15/09/2024
12/10/2024
12/10/2024
23/11/2024
23/11/2024
17/06/2025
10/07/2025
17/07/2025
17/07/2025
14/07/2025
29/11/2025
18/01/2026
18/01/2026
3/04/2026
19/07/2026
19/07/2026
19/07/2026
19/07/2026
19/07/2026
19/07/2026
28/08/2026
28/08/2026
28/08/2026
24/11/2026
28/05/2026
17/11/2026
24/11/2026
24/11/2026
23/01/2027
16/04/2027
17/05/2027
17/05/2027
15/07/2027
15/07/2027
15/07/2027
15/07/2027
15/07/2027
15/07/2027
25/08/2027
10/09/2027
7/10/2027
19/11/2027
19/11/2027
16/02/2028
30/08/2021
1,753,334
75,000
1,858,979
200,000
1,500,000
623,000
1,950,730
50,000
150,000
1,090,000
902,425
750,000
750,000
200,000
200,000
4,201,666
350,000
150,000
590,000
3,333
150,000
300,000
3,638,671
3,999,998
1,346,667
538,667
700,000
400,000
150,000
400,000
800,000
295,000
350,000
200,000
100,000
450,000
10,000
50,000
1,200,000
2,400,000
4,280,000
3,050,000
325,000
350,000
300,000
1,200,000
5,000
200,000
200,000
200,000
100,000
250,000
45,746
45,333,216
4.20
4.05
2.80
2.80
2.86
1.31
1.19
1.54
1.40
1.94
1.76
1.41
1.28
1.52
1.56
1.87
1.87
1.72
1.33
1.45
1.45
1.48
1.62
1.47
1.47
1.47
1.47
1.47
1.47
1.62
1.47
1.98
1.48
1.83
1.80
1.98
3.38
2.51
4.02
3.65
3.75
3.41
3.41
3.41
3.41
3.41
5.76
4.78
3.84
3.60
3.60
2.67
-
107
No option holder has any right under the options plan to participate in any other of our share issues.
Shares issued on exercise of options during the year
Detail of shares or interests issued as a result of the exercise of options during or since the end of the financial year are:
Grant date
10-Jul-15
27-Apr-16
27-Apr-16
30-Jun-16
06-Dec-16
06-Dec-16
13-Jan-17
28-Jun-17
16-Sep-17
13-Oct-17
13-Oct-17
18-Jul-18
15-Jul-18
19-Jan-19
20-Jul-19
20-Jul-19
25-Nov-19
29-May-19
Total
Currency
A$
A$
A$
A$
A$
A$
A$
A$
A$
A$
A$
A$
A$
A$
A$
A$
A$
A$
Number of shares
issued
Issue Price
Amount unpaid per
share
515,000
769,355
116,666
900,000
300,000
426,668
300,000
150,000
16,666
565,000
400,000
944,998
150,000
1,667
523,661
800,002
98,334
100,000
7,078,017
4.20
2.80
2.74
2.20
1.31
1.19
1.65
2.23
1.54
1.94
1.76
1.87
1.72
1.45
1.62
1.47
1.98
1.48
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Indemnification of Officers
During the financial year, we paid premiums in respect of a contract insuring our directors and company secretaries, and all of
our executive officers. The liabilities insured are to the extent permitted by the Corporations Act 2001. Further disclosure required
under section 300(9) of the Corporations Act 2001 is prohibited under the terms of the insurance contract.
Proceedings on Our Behalf
The Corporations Act 2001 allows specified persons to bring, or intervene in, proceedings on our behalf. No proceedings have
been brought or intervened in on our behalf with leave of the Court under section 237 of the Corporations Act 2001.
Non-Audit Services
We may decide to employ the auditor on assignments additional to their statutory audit duties where the auditor’s expertise and
experience are relevant and considered to be important.
The board of directors considers the position and in accordance with advice received from the audit committee, only permits the
provision of the non-audit services compatible with the general standard of independence for auditors imposed by the Corporations
Act 2001.
During both the current and prior financial years, no fees were paid or payable for non-audit services provided by the auditor of
the parent entity, its related practices and non-related audit firms.
Auditor’s Independence Declaration
A copy of the auditor’s independence declaration under Section 307C of the Corporations Act in relation to the audit for the
year ended June 30, 2021 is included in Exhibit 99.2 of this annual report on Form 20-F.
Rounding of Amounts
Our company is of a kind referred to in ASIC Corporations (Rounding in Financial/Directors’ Reports) Instrument 2016/191,
issued by the Australian Securities and Investments Commission, relating to the ‘rounding off’ of amounts in the directors’ report.
108
Unless mentioned otherwise, amounts within this report have been rounded off in accordance with that Legislative Instrument to the
nearest thousand dollars, or in certain cases, to the nearest dollar.
The components of our directors’ report are incorporated in various places within this annual report on the Form 20-F. A table
charting these components is included within ‘Exhibit 99.1 Appendix 4E’.
Directors’ Resolution
This report is made in accordance with a resolution of the directors.
/s/ Joseph R Swedish
Joseph R Swedish
Chairman
Dated: August 31, 2021
/s/ Silviu Itescu
Silviu Itescu
Chief Executive Officer
109
6.C
Board Practices
Our board of directors currently consists of eight members, including seven non-executive directors and one executive director,
our Chief Executive Officer.
Our directors are generally elected to serve three-year terms in a manner similar to a “staggered” board of directors under
Delaware law. No director, except the Managing Director (currently designated as our Chief Executive Officer, Silviu Itescu), may
hold office for a period in excess of three years, or beyond the third annual general meeting following the director’s last election,
whichever is the longer, without submitting himself or herself for re-election. As a result of the staggered terms, not all of our
directors will be elected in any given year. The current term of Mr. Spooner, Mr. Swedish and Ms. Tomasello will expire at the annual
shareholders’ meeting in 2021.
Name
William Burns
Donal O’Dwyer
Eric Rose
Michael Spooner
Joseph Swedish
Shawn Cline Tomasello
Philip Facchina
First election at
AGM
2014
2004
2013
2004
2018
2018
2021
Last election at
AGM
2019
2017
2019
2018
2018
2018
N/A
End of current
term
2022
2023
2022
2021
2021
2021
N/A
We believe that each of our directors has relevant industry experience. The membership of our board of directors is directed by
the following requirements:
•
•
•
•
•
•
•
our Constitution specifies that there must be a minimum of 3 directors and a maximum of 10, and our board of directors
may determine the number of directors within those limits;
we may appoint or remove any director by resolution passed in the general meeting of shareholders;
our directors may appoint any person to be a director, and that person only holds office until the next general meeting at
which time the director may stand for election by shareholders at that meeting;
it is the intention of our board of directors that its membership consists of a majority of independent directors who satisfy
the criteria for independence recommended by the ASX’s Corporate Governance Principles and Recommendations;
the chairperson of our board of directors should be an independent director who satisfies the criteria for independence
recommended by the ASX’s Corporate Governance Principles and Recommendations;
Australia's Corporations Act requires that at least two of our directors must be resident Australians; and
our board of directors should, collectively, have the appropriate level of personal qualities, skills, experience, and time
commitment to properly fulfill its responsibilities or have ready access to such skills where they are not available.
Our board of directors is responsible for, and has the authority to determine, all matters relating to our corporate governance,
including the policies, practices, management and operation. The principal roles and responsibilities of our board of directors are to:
•
•
•
•
•
facilitate board of directors and management accountability to our company and its shareholders;
ensure timely reporting to shareholders;
provide strategic guidance to us, including contributing to the development of, and approving, the corporate strategy;
oversee management and ensure there are effective management processes in place;
monitor:
o
o
o
o
o
organizational performance and the achievement of our strategic goals and objectives;
financial performance including approval of the annual and half-year financial reports and liaison with our auditors;
progress of major capital expenditures and other significant corporate projects including any acquisitions or
divestments;
compliance with our code of conduct;
progress in relation to our diversity objectives and compliance with its diversity policy;
110
•
•
•
•
•
review and approve business plans, the annual budget and financial plans including available resources and major capital
expenditure initiatives;
approve major corporate initiatives;
enhance and protect the reputation of the organization;
oversee the operation of our system for compliance and risk management reporting to shareholders; and
ensure appropriate resources are available to senior management.
Our non-executive directors do not have any service contracts with Mesoblast that provide for benefits upon termination of
employment.
Committees
To assist our board of directors with the effective discharge of its duties, it has established a Nomination and Remuneration
Committee and an Audit and Risk Management Committee. Each committee operates under a specific charter approved by our board
of directors.
Nomination and Remuneration Committee. The members of our Nomination and Remuneration Committee are Messrs. Burns,
O’Dwyer (Chairman), Spooner and Ms. Tomasello, all of whom are independent, non-executive directors. The remuneration
committee is a committee of our board of directors, and is primarily responsible for making recommendations to our board of directors
on:
•
•
•
•
•
•
board appointments;
non-executive director fees;
the executive remuneration framework;
remuneration of executive directors, including the CEO and other key executives;
short-term and long-term incentive awards; and
share ownership plans.
The committee’s objective is to ensure remuneration policies are fair and competitive and in line with similar industry
benchmarks while aligned with our objectives. The remuneration committee seeks independent advice from remuneration consultants
as and when it deems necessary. See “Management—Remuneration.”
Audit and Risk Management Committee. The members of our Audit and Risk Management Committee are Messrs. O’Dwyer,
Spooner (Chairman) and Swedish, all of whom are independent, non-executive directors. This committee oversees, reviews, acts on
and reports on various auditing and accounting matters to our board of directors, including the selection of our independent
accountants, the scope of our annual audits, fees to be paid to the independent accountants, the performance of our independent
accountants and our accounting practices. In addition, the committee oversees, reviews, acts on and reports on various risk
management matters to our board of directors.
The effective management of risk is central to our ongoing success. We have adopted a risk management policy to ensure that:
•
•
•
•
appropriate systems are in place to identify, to the extent that is reasonably practical, all material risks that we face in
conducting our business;
the financial impact of those risks is understood and appropriate controls are in place to limit exposures to them;
appropriate responsibilities are delegated to control the risks; and
any material changes to our risk profile are disclosed in accordance with our continuous disclosure reporting requirements
in Australia.
It is our objective to appropriately balance, protect and enhance the interests of all of our shareholders. Proper behavior by our
directors, officers, employees and those organizations that we contract to carry out work is essential in achieving this objective.
111
We have established a code of conduct, which sets out the standards of behavior that apply to every aspect of our dealings and
relationships, both within and outside Mesoblast. The following standards of behavior apply:
•
•
•
•
•
•
patient well-being;
comply with all laws that govern us and our operations;
act honestly and with integrity and fairness in all dealings with others and each other;
avoid or manage conflicts of interest;
use our assets properly and efficiently for the benefit of all of our shareholders; and
seek to be an exemplary corporate citizen.
6.D
Employees
As of June 30, 2021, we had 83 employees, 48 of whom are based in the United States, 25 of whom are based in Australia,
including our CEO and certain executive team members, 9 of whom are based in Singapore, and 1 of whom is based in Switzerland.
We had 102 and 83 employees as of June 30, 2020 and 2019, respectively.
The table below sets forth the breakdown of the total year-end number of our employees by main category of activity and
geographic area for the past three years:
As of June 30, 2021
USA
Australia
Singapore
Switzerland
Total
As of June 30, 2020
USA
Australia
Singapore
Switzerland
Total
As of June 30, 2019
USA
Australia
Singapore
Switzerland
Total
Research &
Development Commercial Manufacturing Corporate
Total
35
9
6
1
51
1
—
—
—
1
1
—
2
—
3
11
16
1
—
28
48
25
9
1
83
Research &
Development Commercial Manufacturing Corporate
Total
43
7
5
—
55
11
—
—
—
11
3
—
3
—
6
13
15
1
1
30
70
22
9
1
102
Research &
Development Commercial Manufacturing Corporate
Total
37
7
5
—
49
1
—
—
—
1
3
—
2
—
5
10
16
1
1
28
51
23
8
1
83
We have no collective bargaining agreement with our employees. We have not experienced any work stoppages to date and
consider our relations with our employees to be good.
See “Item 6.A Directors and Senior Management – Employee Profile”.
112
6.E
Share Ownership
The table below sets forth information regarding the beneficial ownership of our ordinary shares based on 648,696,070 ordinary
shares outstanding at June 30, 2021 by each of our directors and key management personnel.
We have determined beneficial ownership in accordance with the rules of the SEC - it generally means that a person has a
beneficial ownership of a security if he, she or it possesses sole or shared voting or investment power of that security, including
options that are exercisable within 60 days of June 30, 2021. Ordinary shares subject to options currently exercisable or exercisable
within 60 days of June 30, 2021 are deemed to be outstanding for computing the percentage ownership of the person holding these
options and the percentage ownership of any group of which the holder is a member, however are not deemed outstanding for
computing the percentage of any other person.
Unless otherwise indicated, to our knowledge each shareholder possesses sole voting and investment power over the ordinary
shares listed. None of our shareholders has different voting rights from other shareholders. Unless otherwise indicated, the principal
address of each of the shareholders below is c/o Mesoblast Limited, Level 38, 55 Collins Street, Melbourne 3000, Australia.
Name
Directors and key management personnel:
Silviu Itescu(1)
Josh Muntner (2)
William Burns(3)
Donal O'Dwyer(4)
Eric Rose(5)
Michael Spooner(6)
Joseph Swedish(7)
Shawn Tomasello(8)
Philip Facchina(9)
All directors and key management personnel as a group
(9 persons)
Ordinary Shares
beneficially owned
%
Number
69,991,374
600,001
176,333
1,301,058
113,333
1,126,666
400,000
200,000
341,530
10.8%
*
*
*
*
*
*
*
*
74,250,295
11.4%
*
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
Less than 1% of the outstanding ordinary shares.
Includes (a) 67,756,838 ordinary shares owned by Dr. Itescu, (b) 487,804 ordinary shares owned by Josaka Investments Pty Ltd,
the trustee of Dr. Itescu’s self-managed superannuation fund, (c) 714,286 ordinary shares owned by Tamit Nominees Pty Ltd, an
Australian corporation owned by Dr. Itescu and (d) 1,032,446 ordinary shares subject to options exercisable at a price of A$1.47
per share until July 19, 2026.
Includes 600,001 ordinary shares subject to options of which; 150,000 are exercisable at a price of A$1.72 per share until July
14, 2025, 333,334 are exercisable at a price of A$1.47 per share until July 19, 2026 and 116,667 are exercisable at a price of
A$3.41 per share until July 15, 2027.
Includes (a) 63,000 ordinary shares owned by Mr. Burns and (b) 113,333 ordinary shares subject to options of which; 80,000
exercisable at a price of A$1.33 per share until November 29, 2025 and 33,333 exercisable at a price of A$1.83 per share until
November 17, 2026.
Includes (a) 1,234,392 ordinary shares owned by Dundrum Investments Ltd. as trustee for The O’Dwyer Family Trust. Mr.
O’Dwyer and his spouse are the sole shareholders of Dundrum Investments Ltd and (b) 66,666 ordinary shares subject to
options exercisable at a price of A$1.33 per share until November 29, 2025.
Includes 113,333 ordinary shares subject to options of which; 80,000 are exercisable at a price of A$1.33 per share until
November 29, 2025 and 33,333 are exercisable at a price of A$1.83 per share until November 17, 2026.
Includes (a) 1,060,000 ordinary shares owned by Mr. Spooner and (b) 66,666 ordinary shares subject to options exercisable at a
price of A$1.33 per share until November 29, 2025.
Includes 400,000 ordinary shares subject to options of which; 200,000 are exercisable at a price of A$1.52 per share until June
17, 2025 and 200,000 are exercisable at a price of A$1.48 per share until April 3, 2026.
Includes 200,000 ordinary shares subject to options exercisable at a price of A$1.56 per share until July 10, 2025.
Includes (a) 273,224 ordinary shares owned by HNP, LLC and (b) 68,306 warrants over ordinary shares owned by HNP, LLC.
113
Item 7.
Major Shareholders and Related Party Transactions
7.A
Major Shareholders
The following table and accompanying footnotes present certain information regarding the beneficial ownership of our ordinary
shares based on 648,696,070 ordinary shares outstanding at June 30, 2021 by each person known by us to be the beneficial owner of
more than 5% of our ordinary shares. Based upon information known to us, as of June 30, 2021 we had 37 shareholders (ordinary
shares) in the United States. These shareholders held an aggregate of 155,392,384 of our ordinary shares, or approximately 24% of our
outstanding ordinary shares. None of our shareholders has different voting rights from other shareholders.
Name
5% or Greater Shareholders:
Silviu Itescu(1)
M&G Investment Group(2)
Thorney Holdings(3)
Ordinary Shares
beneficially owned
Number
%
69,991,374
53,392,209
34,155,365
10.8%
8.2%
5.3%
(1)
(2)
(3)
Includes (a) 67,756,838 ordinary shares owned by Dr. Itescu, (b) 487,804 ordinary shares owned by Josaka Investments Pty Ltd,
the trustee of Dr. Itescu’s self-managed superannuation fund and (c) 714,286 ordinary shares owned by Tamit Nominees Pty
Ltd, an Australian corporation owned by Dr. Itescu and (d) 1,032,446 ordinary shares subject to options exercisable at a price of
A$1.47 per share until July 19, 2026.
Includes ordinary shares owned indirectly through custodial accounts, over which shares M&G Investment Group retains voting
and dispositive power, as well as 1,639,344 warrants. The address for M&G Investment Group is 5 Laurence Pountney Hill,
London EC4R 0HH, United Kingdom.
Includes ordinary shares owned indirectly through custodial accounts, over which shares Thorney Holdings retains voting and
dispositive power, as well as 819,672 warrants. The address for Thorney Holdings is 55 Collins Street, Level 39, Melbourne,
Victoria 3000, Australia.
To our knowledge, there have not been any significant changes in the ownership of our ordinary shares by major shareholders
over the past three years, except as follows (which is based on substantial shareholder notices filed with the ASX and SEC).
•
M&G Investment Group reported on October 16, 2018 that it disposed of 1,348,839 ordinary shares (including 42,631
ADSs, each representing 5 ordinary shares) between December 13, 2017 and September 11, 2018, and that in total it held
68,041,831 ordinary shares (including 1,490,212 ADSs, each representing 5 ordinary shares), or 13.67% of the total
voting power as of that date. It reported on January 30, 2019 that in total it held 67,993,821 ordinary shares or 13.67% of
the total voting power as of December 31, 2018. It reported that as of July 10, 2019 in total it held 65,636,115 ordinary
shares (including 1,491,414 ADSs, each representing 5 ordinary shares), or 13.15% of the total voting power as of that
date. It reported that as of on October 8, 2019 in total it held 70,636,115 ordinary shares (including 1,491,414 ADSs, each
representing 5 ordinary shares), or 13.15% of the total voting power as of that date. It reported that as of May 25, 2020 in
total it held 70,068,935 ordinary shares (including 1,391,475 ADSs, each representing 5 ordinary shares), or 12.05% of
the total voting power as of that date. It reported that as of August 6, 2020 in total it held 64,531,906 ordinary shares
(including 1,385,525 ADSs, each representing 5 ordinary shares), or 11.04% of the total voting power as of that date. It
reported that as of August 20, 2020 in total it held 58,000,971 ordinary shares (including 1,142,337 ADSs, each
representing 5 ordinary shares), or 9.91% of the total voting power as of that date. It reported that as of September 3, 2020
in total it held 51,752,865 ordinary shares (including 908,090 ADSs, each representing 5 ordinary shares), or 8.84% of the
total voting power as of that date.
7.B
Related Party Transactions
The Company has not entered into any related party transactions during the year ended June 30, 2021 other than compensation
made to Directors and other members of key management personnel, see “Item 6.B Compensation”.
7.C
Interests of Experts and Counsel
Not applicable.
114
Item 8.
Financial Information
8.A
Consolidated Statements and Other Financial Information
See “Item 18. Financial Statements.”
Legal Proceedings
In October 2020, in light of the Complete Response Letter released by the FDA and the decline in the market price of our ADS,
a purported class action lawsuit was filed in the U.S. Federal District Court for the Southern District of New York on behalf of
purchasers or acquirers of our ADSs against the Company, its Chief Executive Officer, its Chief Financial Officer and its Chief
Medical Officer for alleged violations of the U.S. Securities Exchange Act of 1934. The Company will vigorously defend this and any
other similarly-based litigation should it arise. The Company cannot provide any assurance as to the possible outcome or cost to us
from the lawsuit, particularly as it is at an early stage, nor how long it may take to resolve such lawsuit. Thus, the Company has not
accrued any amounts in connection with such legal proceedings other than ongoing attorney’s fees.
Dividend policy
Since our inception, we have not declared or paid any dividends on our shares. We intend to retain any earnings for use in our
business and do not currently intend to pay cash dividends on our ordinary shares. Dividends, if any, on our outstanding ordinary
shares will be declared by and subject to the discretion of our board of directors, and subject to Australian law.
Any dividend we declare will be paid to the holders of ADSs, subject to the terms of the deposit agreement, to the same extent
as holders of our ordinary shares, to the extent permitted by applicable law and regulations, less the fees and expenses payable under
the deposit agreement. Any dividend we declare will be distributed by the depositary bank to the holders of our ADSs, subject to the
terms of the deposit agreement. See “Item 12.D. Description of American Depositary Shares.”
8.B
Significant Changes
There were no events that have arisen subsequent to June 30, 2021 and prior to the signing of this report that would likely have a
material impact on the financial results presented.
Item 9.
The Offer and Listing
9.A
Offer and Listing Details
Our ordinary shares have been listed in Australia on the Australian Securities Exchange (ASX) since December 2004. Our
ordinary shares have been trading under the symbol “MSB”.
American Depositary Shares (“ADSs”), each representing five ordinary shares, are available in the US through an American
Depositary Receipts (“ADR”) program. This program was established under the deposit agreement which we entered into with JP
Morgan Chase Bank N.A. as depositary and our ADR holders. Our ADRs have been listed on the Nasdaq Global Select Market since
August 2015 and are traded under the symbol “MESO”.
9.B
Plan of Distribution
Not applicable.
9.C
Markets
See “Item 9.A Offer and Listing Details.”
9.D
Selling Shareholders
Not applicable.
9.E
Dilution
Not applicable.
115
9.F
Expenses of the Issue
Not applicable.
Item 10. Additional Information
10.A
Share Capital
Not applicable.
10.B
Memorandum and Articles of Association
Our Constitution is similar in nature to the bylaws of a U.S. corporation. It does not provide for or prescribe any specific
objectives or purposes of Mesoblast. Our Constitution is subject to the terms of the ASX Listing Rules and the Australian
Corporations Act. It may be modified or repealed and replaced by special resolution passed at a meeting of shareholders, which a
resolution is passed by at least 75% of the votes cast by shareholders (including proxies and representatives of shareholders) entitled to
vote on the resolution.
Under Australian law, a company has the legal capacity and powers of an individual both within and outside Australia. The
material provisions of our Constitution are summarized below. This summary is not intended to be complete nor to constitute a
definitive statement of the rights and liabilities of our shareholders, and is qualified in its entirety by reference to the complete text of
our Constitution, a copy of which is on file with the SEC.
Directors
Interested Directors
Except as permitted by the Corporations Act and the ASX Listing Rules, a director must not vote in respect of a matter that is
being considered at a directors' meeting in which the director has a material personal interest according to our Constitution. Such
director must not be counted in a quorum, must not vote on the matter and must not be present at the meeting while the matter is being
considered.
Pursuant to our Constitution, the fact that a director holds office as a director, and has fiduciary obligations arising out of that
office will not require the director to account to us for any profit realized by or under any contract or arrangement entered into by or
on behalf of Mesoblast and in which the director may have an interest.
Unless a relevant exception applies, the Corporations Act requires our directors to provide disclosure of certain interests and
prohibits directors of companies listed on the ASX from voting on matters in which they have a material personal interest and from
being present at the meeting while the matter is being considered. In addition, unless a relevant exception applies, the Corporations
Act and the ASX Listing Rules require shareholder approval of any provision of financial benefits (including the issue by us of
ordinary shares and other securities) to our directors, including entities controlled by them and certain members of their families.
Borrowing Powers Exercisable by Directors
Pursuant to our Constitution, our business is managed by our board of directors. Our board of directors has the power to raise or
borrow money, and charge any of our property or business or all or any of our uncalled capital, and may issue debentures or give any
other security for any of our debts, liabilities or obligations or of any other person, and may guarantee or become liable for the
payment of money or the performance of any obligation by or of any other person.
Election, Removal and Retirement of Directors
We may appoint or remove any director by resolution passed in a general meeting of shareholders. Additionally, our directors
are elected to serve three-year terms in a manner similar to a “staggered” board of directors under Delaware law. No director except
the Managing Director (currently designated as our chief executive officer, Silviu Itescu) may hold office for a period in excess of
three years, or beyond the third annual general meeting following the director’s last election, whichever is the longer, without
submitting himself or herself for re-election.
A director who is appointed during the year by the other directors only holds office until the next general meeting at which time
the director may stand for election by shareholders at that meeting.
116
In addition, provisions of the Corporations Act apply where at least 25% of the votes cast on a resolution to adopt our
remuneration report (which resolution must be proposed each year at our annual general meeting) are against the adoption of the
report at two successive annual general meetings. Where these provisions apply, a resolution must be put to a vote at the second
annual general meeting to the effect that a further meeting, or a spill meeting, take place within 90 days. At the spill meeting, the
directors in office when the remuneration report was considered at the second annual general meeting (other than the Managing
Director) cease to hold office and resolutions to appoint directors (which may involve re-appointing the former directors) are put to a
vote.
Voting restrictions apply in relation to the resolutions to adopt our remuneration report and to propose a spill meeting. These
restrictions apply to our key management personnel and their closely related parties. See “Rights and Restrictions on Classes of
Shares—Voting Rights” below.
Pursuant to our Constitution, a person is eligible to be elected as a director at a general meeting only if:
•
•
•
•
the person is in office as a director immediately before the meeting, in respect of an election of directors at a general
meeting that is a spill meeting as defined in section 250V(1) of the Corporations Act;
the person has been nominated by the directors before the meeting;
where the person is a shareholder, the person has, at least 35 business days but no more than 90 business days before the
meeting, given to us a notice signed by the person stating the person's desire to be a candidate for election at the meeting;
or
where the person is not a shareholder, a shareholder intending to nominate the person for election at that meeting has, at
least 35 business days but no more than 90 business days before the meeting, given to us a notice signed by the
shareholder stating the shareholder's intention to nominate the person for election, and a notice signed by the person
stating the person's consent to the nomination.
Share Qualifications
There are currently no requirements for directors to own our ordinary shares in order to qualify as directors.
Rights and Restrictions on Classes of Shares
Subject to the Corporations Act and the ASX Listing Rules, the rights attaching to our ordinary shares are detailed in our
Constitution. Our Constitution provides that any of our ordinary shares may be issued with preferential, deferred or special rights,
privileges or conditions, with any restrictions in regard to dividends, voting, return of share capital or otherwise as our board of
directors may determine from time to time. Subject to the Corporations Act, the ASX Listing Rules and any rights and restrictions
attached to a class of shares, we may issue further ordinary shares on such terms and conditions as our board of directors resolve.
Currently, our outstanding ordinary share capital consists of only one class of ordinary shares.
Dividend Rights
Our board of directors may from time to time determine to pay dividends to shareholders; however, no dividend is payable
except in accordance with the thresholds set out in the Corporations Act.
Voting Rights
Under our Constitution, the general conduct and procedures of each general meeting of shareholders will be determined by the
chairperson, including any procedures for casting or recording votes at the meeting whether on a show of hands or on a poll. A poll
may be demanded by the chairman of the meeting; by at least five shareholders present and having the right to vote on at the meeting;
or any shareholder or shareholders representing at least 5% of the votes that may be cast on the resolution on a poll. On a show of
hands, each shareholder entitled to vote at the meeting has one vote regardless of the number of ordinary shares held by such
shareholder. If voting takes place on a poll, rather than a show of hands, each shareholder entitled to vote has one vote for each
ordinary share held and a fractional vote for each ordinary share that is not fully paid, such fraction being equivalent to the proportion
of the amount that has been paid (not credited) of the total amounts paid and payable, whether or not called (excluding amounts
credited), to such date on that ordinary share.
Under Australian law, an ordinary resolution is passed on a show of hands if it is approved by a simple majority (more than
50%) of the votes cast by shareholders present (in person or by proxy) and entitled to vote. If a poll is demanded, an ordinary
resolution is passed if it is approved by holders representing a simple majority of the total voting rights of shareholders present (in
117
person or by proxy) who (being entitled to vote) vote on the resolution. Special resolutions require the affirmative vote of not less than
75% of the votes cast by shareholders present (in person or by proxy) and entitled to vote at the meeting.
Pursuant to our Constitution, each shareholder entitled to attend and vote at a meeting may attend and vote:
•
•
•
in person physically or by electronic means;
by proxy, attorney or by representative; or
other than in relation to any clause which specifies a quorum, a member who has duly lodged a valid vote delivered to us
by post, fax or other electronic means approved by the directors in accordance with the Constitution.
Under Australian law, shareholders of a public listed company are generally not permitted to approve corporate matters by
written consent. Our Constitution does not specifically provide for cumulative voting.
Note that ADS holders may not directly vote at a meeting of the shareholders but may instruct the depositary to vote the number
of deposited ordinary shares their ADSs represent. Under voting by a show of hands, multiple “yes” votes by ADS holders will only
count as one “yes” vote and will be negated by a single “no” vote, unless a poll is demanded.
There are a number of circumstances where the Corporations Act or the ASX Listing Rules prohibit or restrict certain
shareholders or certain classes of shareholders from voting. For example, key management personnel whose remuneration details are
included elsewhere in this prospectus are prohibited from voting on the resolution that must be proposed at each annual general
meeting to adopt our remuneration report, as well as any resolution to propose a spill meeting. An exception applies to exercising a
directed proxy which indicates how the proxy is to vote on the proposed resolution on behalf of someone other than the key
management personnel or their closely related parties; or that person is chair of the meeting and votes an undirected proxy where the
shareholder expressly authorizes the chair to exercise that power. Key management personnel and their closely related parties are also
prohibited from voting undirected proxies on remuneration related resolutions. A similar exception to that described above applies if
the proxy is the chair of the meeting.
Right to Share in Our Profits
Subject to the Corporations Act and pursuant to our Constitution, our shareholders are entitled to participate in our profits by
payment of dividends. The directors may by resolution declare a dividend or determine a dividend is payable, and may fix the amount,
the time for and method of payment.
Rights to Share in the Surplus in the Event of Winding Up
Our Constitution provides for the right of shareholders to participate in a surplus in the event of our winding up.
Redemption Provisions
Under our Constitution and subject to the Corporations Act, the directors have power to issue and allot shares with any
preferential, deferred or special rights, privileges or conditions; with any restrictions in regard to the dividend, voting, return of capital
or otherwise; and preference shares which are liable to be redeemed or converted.
Sinking Fund Provisions
Our Constitution allows our directors to set aside any amount available for distribution as a dividend such amounts by way of
reserves as they think appropriate before declaring or determining to pay a dividend, and may apply the reserves for any purpose for
which an amount available for distribution as a dividend may be properly applied. Pending application or appropriation of the
reserves, the directors may invest or use the reserves in our business or in other investments as they think fit.
Liability for Further Capital Calls
According to our Constitution, our board of directors may make any calls from time to time upon shareholders in respect of all
monies unpaid on partly paid shares respectively held by them, subject to the terms upon which any of the partly paid shares have
been issued. Each shareholder is liable to pay the amount of each call in the manner, at the time and at the place specified by our board
of directors. Calls may be made payable by instalment.
118
Provisions Discriminating Against Holders of a Substantial Number of Shares
There are no provisions under our Constitution discriminating against any existing or prospective holders of a substantial
number of our ordinary shares.
Variation or Cancellation of Share Rights
The rights attached to shares in a class of shares may only be varied or cancelled by a special resolution of shareholders,
together with either:
•
•
a special resolution passed at a separate meeting of members holding shares in the class; or
the written consent of members with at least 75% of the votes in the class.
General Meetings of Shareholders
General meetings of shareholders may be called by our board of directors or, under the Corporations Act, by a single director.
Except as permitted under the Corporations Act, shareholders may not convene a meeting. Under the Corporations Act, shareholders
with at least 5% of the votes that may be cast at a general meeting may call and arrange to hold a general meeting. The Corporations
Act requires the directors to call and arrange to hold a general meeting on the request of shareholders with at least 5% of the votes that
may be cast at a general meeting. Notice of the proposed meeting of our shareholders is required at least 28 days prior to such meeting
under the Corporations Act.
No business shall be transacted at any general meeting unless a quorum is present at the time when the meeting proceeds to
business. Under our Constitution, the presence, in person or by proxy, attorney or representative, of two shareholders constitutes a
quorum, or if we have less than two shareholders, then those shareholders constitute a quorum. If a quorum is not present within 30
minutes after the time appointed for the meeting, the meeting must be either dissolved if it was requested or called by shareholders or
adjourned in any other case. A meeting adjourned for lack of a quorum is adjourned to the same day in the following week at the same
time and place, unless otherwise decided by our directors. The reconvened meeting is dissolved if a quorum is not present within 30
minutes after the time appointed for the meeting.
Change of Control
Takeovers of listed Australian public companies, such as Mesoblast, are regulated by the Corporations Act, which prohibits the
acquisition of a “relevant interest” in issued voting shares in a listed company if the acquisition will lead to that person’s or someone
else’s voting power in Mesoblast increasing from 20% or below to more than 20% or increasing from a starting point that is above
20% and below 90% (“Takeovers Prohibition”), subject to a range of exceptions.
Generally, a person will have a relevant interest in securities if the person:
•
•
•
is the holder of the securities or the holder of an ADS over the shares;
has power to exercise, or control the exercise of, a right to vote attached to the securities; or
has the power to dispose of, or control the exercise of a power to dispose of, the securities (including any indirect or direct
power or control)
If, at a particular time:-
•
•
•
a person has a relevant interest in issued securities; and
the person has:
o
o
o
entered or enters into an agreement with another person with respect to the securities;
given or gives another person an enforceable right, or has been or is given an enforceable right by another person, in
relation to the securities; or
granted or grants an option to, or has been or is granted an option by, another person with respect to the securities;
and
the other person would have a relevant interest in the securities if the agreement were performed, the right enforced or the
option exercised,
then, the other person is taken to already have a relevant interest in the securities.
119
There are a number of exceptions to the above Takeovers Prohibition on acquiring a relevant interest in issued voting shares
above 20%. In general terms, some of the more significant exceptions include:
•
•
•
•
•
•
•
•
•
•
•
when the acquisition results from the acceptance of an offer under a formal takeover bid;
when the acquisition is conducted on market by or on behalf of the bidder during the bid period for a full takeover bid that
is unconditional or only conditional on certain 'prescribed' matters set out in the Corporations Act;
when the acquisition has been previously approved by resolution passed at general meeting by shareholders of Mesoblast;
an acquisition by a person if, throughout the six months before the acquisition, that person or any other person has had
voting power in Mesoblast of at least 19% and, as a result of the acquisition, none of the relevant persons would have
voting power in Mesoblast more than three percentage points higher than they had six months before the acquisition;
when the acquisition results from the issue of securities under a pro rata rights issue;
when the acquisition results from the issue of securities under a dividend reinvestment plan or bonus share plan;
when the acquisition results from the issue of securities under certain underwriting arrangements;
when the acquisition results from the issue of securities through a will or through operation of law;
an acquisition that arises through the acquisition of a relevant interest in another company listed on the ASX or other
Australian financial market or a foreign stock exchange approved in writing by ASIC;
an acquisition arising from an auction of forfeited shares; or
an acquisition arising through a compromise, arrangement, liquidation or buy-back.
A formal takeover bid may either be a bid for all securities in the bid class or a fixed proportion of such securities, with each
holder of bid class securities receiving a bid for that proportion of their holding. Under our Constitution, a proportionate takeover bid
must first be approved by resolution of our shareholders in a general meeting before it may proceed.
Breaches of the takeovers provisions of the Corporations Act are criminal offenses. In addition, ASIC and, on application by
ASIC or an interested party, such as a shareholder, the Australian Takeovers Panel have a wide range of powers relating to breaches of
takeover provisions, including the ability to make orders cancelling contracts, freezing transfers of, and rights (including voting rights)
attached to, securities, and forcing a party to dispose of securities including by vesting the securities in ASIC for sale. There are
certain defenses to breaches of the takeover provisions provided in the Corporations Act.
Ownership Threshold
There are no provisions in our Constitution that require a shareholder to disclose ownership above a certain threshold. The
Corporations Act, however, requires a substantial shareholder to notify us and the ASX once a 5% interest in our ordinary shares is
obtained. Further, once a shareholder has (alone or together with associates) a 5% or greater interest in us, such shareholder must
notify us and the ASX of any increase or decrease of 1% or more in its interest in our ordinary shares. In addition, the Constitution
requires a shareholder to provide information to the Company in relation to its entry into any arrangement restricting the transfer or
other disposal of shares, which are of the nature of arrangements that Mesoblast is required to disclose under the ASX Listing Rules.
Following our initial public offering in the United States, our shareholders are also subject to disclosure requirements under U.S.
securities laws.
Issues of Shares and Change in Capital
Subject to our Constitution, the Corporations Act, the ASX Listing Rules and any other applicable law, we may at any time
grant options over unissued shares and issue shares on any terms, with any preferential, deferred or special rights, privileges or
conditions; with any restrictions in regard to dividend, voting, return of capital or otherwise, and for the consideration and other terms
that the directors determine. Our power to issue shares includes the power to issue bonus shares (for which no consideration is payable
to Mesoblast), preference shares and partly paid shares.
Subject to the requirements of our Constitution, the Corporations Act, the ASX Listing Rules and any other applicable law,
including relevant shareholder approvals, we may reduce our share capital (provided that the reduction is fair and reasonable to our
shareholders as a whole, does not materially prejudice our ability to pay creditors and obtains the necessary shareholder approval) or
buy back our ordinary shares including under an equal access buy-back or on a selective basis. Under the Constitution, the directors
may do anything required to give effect to any resolution altering or approving the reduction of our share capital.
120
Access to and Inspection of Documents
Inspection of our records is governed by the Corporations Act. Any member of the public has the right to inspect or obtain
copies of our share registers on the payment of a prescribed fee. Shareholders are not required to pay a fee for inspection of our share
registers or minute books of the meetings of shareholders. Other corporate records, including minutes of directors’ meetings, financial
records and other documents, are not open for inspection by shareholders. Where a shareholder is acting in good faith and an
inspection is deemed to be made for a proper purpose, a shareholder may apply to the court to make an order for inspection of our
books.
10.C
Material Contracts
Manufacturing Service Agreements with Lonza Bioscience Singapore Pte. Ltd.
In September 2011, we entered into a manufacturing services agreement, or MSA, with Lonza Walkersville, Inc. and Lonza
Bioscience Singapore Pte. Ltd., collectively referred to as Lonza, a global leader in biopharmaceutical manufacturing. Under the
MSA, we pay Lonza on a fee for service basis to provide us with manufacturing process development capabilities for our product
candidates, including formulation development, establishment and maintenance of master cell banks, records preparation, process
validation, manufacturing and other services.
We have agreed to order a certain percentage of our clinical requirements and commercial requirements for MPC products from
Lonza. Lonza has agreed not to manufacture or supply commercially biosimilar versions of any of our product candidates to any third
party, during the term of the MSA, subject to our meeting certain thresholds for sales of our products.
We can trigger a process requiring Lonza to construct a purpose-built manufacturing facility exclusively for our product
candidates. In return if we exercise this option, we will purchase agreed quantities of our product candidates from this facility. We also
have a right to buy out this manufacturing facility at a pre-agreed price two years after the facility receives regulatory approval.
The MSA will expire on the three-year anniversary of the date of the first commercial sale of product supplied under the MSA,
unless it is sooner terminated. We have the option of extending the MSA for an additional 10 years, followed by the option to extend
for successive three-year periods subject to Lonza’s reasonable consent. We may terminate the MSA with two years prior written
notice, and Lonza may terminate with five years prior written notice. The MSA may also terminate for other reasons, including if the
manufacture or development of a product is suspended or abandoned due to the results of clinical trials or guidance from a regulatory
authority. In the event we request that Lonza construct the manufacturing facility described above, neither we nor Lonza may
terminate before the third anniversary of the date the facility receives regulatory approval to manufacture our product candidates,
except in certain limited circumstances. Upon expiration or termination of the MSA, we have the right to require Lonza to transfer
certain technologies and lease the Singapore facility or the portion of such facility where our product candidates are manufactured,
subject to good faith negotiations.
We currently rely, and expect to continue to rely, on Lonza for the manufacture of our MPC product candidates for preclinical
and clinical testing, as well as for commercial manufacture of our MPC product candidates if marketing approval is obtained.
In October 2019, we entered into an agreement with Lonza for commercial manufacture of remestemcel-L for pediatric SR-
aGVHD. This agreement will facilitate inventory build ahead of the planned US market launch of remestemcel-L and commercial
supply to meet Mesoblast’s long-term market projections. The agreement provides for Lonza to expand its Singapore cGMP facilities
if required to meet long-term growth and capacity needs for the product. Additionally, it anticipates introduction of new technologies
and process improvements which are expected to result in significant increases in yields and efficiencies.
Under the agreement, we agree to order a certain percentage of our commercial requirements for remestemcel-L from Lonza.
The agreement is subject to standard provisions for termination and its effects, including termination by either party for uncured,
material breach of the other, by us in the event of FDA rejects our BLA filing for remestemcel-L and after a specified minimum period
following the initiation date by either party, on advance notice to the other, which in the case Lonza is the terminating party is
intended to provide us sufficient time to transfer the manufacture of the product to an alternative manufacturer.
License Agreement with Grünenthal GmbH
In September 2019, we entered into a strategic partnership with Grünenthal GmbH (Grünenthal) to develop and commercialize
MPC-06-ID, the Company’s Phase 3 allogeneic cell therapy candidate for the treatment of chronic low back pain due to degenerative
disc disease in patients who have exhausted conservative treatment options. The agreement was amended by the parties in June 2021.
Under the partnership, Grünenthal will have exclusive commercialization rights to MPC-06-ID for Europe and Latin America. We
may receive up to $112.5 million in upfront and milestone payments prior to product launch, inclusive of $17.5 million already
received, if certain clinical and regulatory milestones are satisfied and reimbursement targets are achieved. Cumulative milestone
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payments could exceed $1.0 billion depending on the final outcome of Phase 3 studies and patient adoption. We will also receive
tiered double-digit royalties on product sales. There cannot be any assurance as to the total amount of future milestone and royalty
payments that Mesoblast will receive nor when they will be received.
Grünenthal is able to terminate the agreement with a specified period of notice without cause, or on shorter notice in the case of
certain clinical, regulatory and commercial events. We have termination rights with respect to certain patent challenges by Grünenthal.
Either party may terminate the agreement on material breach of the agreement if such breach is not cured within the specified cure
period or if certain events related to bankruptcy of the other party occurs. For more information, see “Item 18. Financial Statements -
Note 3 – Revenue recognition.”
Agreements with JCR Pharmaceuticals Co., Ltd.
In October 2013, we acquired all of Osiris Therapeutics, Inc.’s business and assets related to culture expanded MSCs. These
assets included assumption of a collaboration agreement with JCR (“JCR Agreement”), which will continue in existence until the later
of 15 years from the first commercial sale of any product covered by the agreement and expiration of the last Osiris patent covering
any such product. JCR is a research and development oriented pharmaceutical company in Japan. Under the JCR Agreement we
assumed from Osiris, JCR has the right to develop our MSCs in two fields for the Japanese market: exclusive in conjunction with the
treatment of hematological malignancies by the use of HSCs derived from peripheral blood, cord blood or bone marrow, or the First
JCR Field; and non-exclusive for developing assays that use liver cells for non-clinical drug screening and evaluation, or the Second
JCR Field. Under the JCR Agreement, JCR obtained rights in Japan to our MSCs, for the treatment of aGVHD. JCR also has a right of
first negotiation to obtain rights to commercialize MSC-based products for additional orphan designations in Japan. We retain all
rights to those products outside of Japan.
JCR received full approval in September 2015 for its MSC-based product for the treatment of children and adults with aGVHD,
TEMCELL. TEMCELL is the first culture-expanded allogeneic cell therapy product to be approved in Japan. It was launched in Japan
in February 2016.
Under the JCR Agreement, JCR is responsible for all development and manufacturing costs including sales and marketing
expenses. With respect to the First JCR Field, we have received all sales milestone payments, a total of $3.0 million. Ongoing we are
entitled to escalating double-digit royalties in the twenties. These royalties are subject to possible renegotiation downward in the event
of competition from non-infringing products in Japan. With respect to the Second JCR Field, we are entitled to a double digit profit
share in the fifties.
Intellectual property is licensed both ways under the JCR Agreement, with JCR receiving exclusive and non-exclusive rights as
described above from us and granting us non-exclusive, royalty-free rights (excluding in the First JCR Field and Second JCR Field in
Japan) under the intellectual property arising out of JCR’s development or commercialization of MSC-based products licensed in
Japan.
JCR has the right to terminate the JCR Agreement for any reason, and we have a limited right to terminate the JCR Agreement,
including a right to terminate in the event of an uncured material breach by JCR. In the event of a termination of the JCR Agreement
other than for our breach, JCR must provide us with its owned product registrations and technical data related to MSC-based products
licensed in Japan and all licenses of our intellectual property rights will revert to us.
We have expanded our partnership with JCR in Japan for two new indications: for wound healing in patients with EB in October
2018, and for neonatal HIE, a condition suffered by newborns who lack sufficient blood supply and oxygen to the brain, in June 2019.
We will receive royalties on TEMCELL product sales for EB and HIE, if and when such indications receive marketing approval in
Japan.
We have the right to use all safety and efficacy data generated by JCR in Japan to support our development and
commercialization plans for our MSC product candidate remestemcel-L in the United States and other major healthcare markets,
including for GVHD, EB and HIE.
Loan Agreement with Hercules
In March 2018, we entered into a loan and security agreement with Hercules for a $75.0 million non-dilutive, secured four-year
credit facility with an initial interest rate of 9.45%. We drew the first tranche of $35.0 million on closing and a further tranche of $15.0
million was drawn in January 2019. The loan matures in March 2022. In May 2021, we amended the terms of the loan and security
agreement to extend the interest-only period to October 1, 2021. In August 2021, we amended the terms of the loan and security
agreement to extend the interest-only period to January 1, 2022. Principal repayments can be further deferred to the loan maturity date
of March 2022 if certain milestones are satisfied. Interest on the loan is payable monthly in arrears on the 1st day of the month. The
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interest rate is floating. It is computed daily based on the actual number of days elapsed and it is the greater of either 9.45% or the
prime rate as reported in the Wall Street Journal plus a certain margin. At June 30, 2019, in line with increases in the U.S. prime rate,
the interest rate was 10.45%. On August 1, September 19 and October 31, in line with the decreases in the U.S. prime rate, the interest
rate on the loan decreased to 10.20%, 9.95% and 9.70%, respectively and remains at 9.70% at June 30, 2021 in line with the amended
terms of the loan agreement. The loan agreement contains certain covenants, see “Item 5.B Liquidity and Capital Resource –
Borrowings.”
Loan Agreement with NovaQuest
In June 2018, we entered into a non-dilutive secured loan with NovaQuest for $40.0 million. We drew the first tranche of $30.0
on closing. There is a four-year interest only period, until July 2022, with the principal repayable in equal quarterly instalments over
the remaining period of the loan. The loan matures in July 2026. Interest on the loan will accrue at a fixed rate of 15% per annum. The
loan agreement contains certain covenants, see “Item 5.B Liquidity and Capital Resource – Borrowings.”
All interest and principal payments will be deferred until after the first commercial sale of our allogeneic product candidate
MSC-100-IV in pediatric patients with steroid refractory aGVHD, in the United States and other geographies excluding Asia
(“pediatric aGVHD”). We can elect to prepay all outstanding amounts owing at any time prior to maturity, subject to a prepayment
charge, and may decide to do so if net sales of pediatric aGVHD are significantly higher than current forecasts.
If there are no net sales of pediatric aGVHD, the loan is only repayable on maturity in 2026. If in any annual period 25% of net
sales of pediatric aGVHD exceed the amount of accrued interest owing and from 2022, principal and accrued interest owing (“the
payment cap”), Mesoblast will pay the payment cap and an additional portion of excess sales which may be used for early prepayment
of the loan. If in any annual period 25% of net sales of pediatric aGVHD is less than the payment cap, then the payment is limited to
25% of net sales of pediatric aGVHD. Any unpaid interest will be added to the principal amounts owing and will accrue further
interest. At maturity date, any unpaid loan balances are repaid.
Osiris Acquisition—Continuing Obligations
In October 2013, we and Osiris entered into a purchase agreement, as amended, or the Osiris Purchase Agreement, under which
we acquired all of Osiris’ business and assets related to culture expanded MSCs. Pursuant to the Osiris Purchase Agreement, we also
agreed to make certain milestone and royalty payments to Osiris pertaining to remestemcel-L for the treatment of aGVHD and
Crohn’s disease. Each milestone payment is for a fixed dollar amount and may be paid in cash or our ordinary shares or ADSs, at our
option. The maximum amount of future milestone payments we may be required to make to Osiris is $40.0 million. Any ordinary
shares or ADSs we issue as consideration for a milestone payment will be subject to a contractual one year holding period, which may
be waived in our discretion. In the event that the price of our ordinary shares or ADSs decreases between the issue date and the
expiration of any applicable holding period, we will be required to make an additional payment to Osiris equal to the reduction in the
share price multiplied by the amount of issued shares under that milestone payment. This additional payment can be made either
wholly in cash or 50% in cash and 50% in our ordinary shares, in our discretion. We have also agreed to pay varying earnout amounts
as a percentage of annual net sales of acquired products, ranging from low single-digit to 10% of annual sales in excess of $750.0
million. These royalty payments will cease after the earlier of a ten year commercial sales period and the first sale of a relevant
competing product. The first royalty payments were made in 2016.
Agreements with Tasly Pharmaceutical Group
In July 2018, we entered into a Development and Commercialization Agreement with Tasly.
The Development and Commercialization Agreement provides Tasly with exclusive rights to develop, manufacture and
commercialize in China MPC-150-IM for the treatment or prevention of chronic heart failure and MPC-25-IC for the treatment or
prevention of acute myocardial infarction. Tasly will fund all development, manufacturing and commercialization activities in China
for MPC-150-IM and MPC-25-IC. On closing, we received a $20.0 million upfront technology access fee. Further, we will receive
$25.0 million on product regulatory approvals in China. Mesoblast will receive double-digit escalating royalties on net product sales.
Mesoblast is eligible to receive six escalating milestone payments upon the product candidates reaching certain sales thresholds in
China.
The Development and Commercialization Agreement provides that Tasly can terminate this agreement with a specified amount
of notice, on the later of (a) third anniversary of the agreement coming into effect and (b) receipt of marketing approval in China for
each of MPC-150-IM or MPC-25-IC. Mesoblast has termination rights with respect to certain patent challenges by Tasly and if certain
competing activities are undertaken by Tasly. Either party may terminate the agreement on material breach of the agreement if such
breach is not cured within the specified cure period or if certain events related to bankruptcy of the other party occurs.
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TiGenix NV – patent license for treatment of fistulae
In December 2017, we entered into a Patent License Agreement with TiGenix NV, now a wholly owned subsidiary of Takeda,
which granted Takeda exclusive access to certain of our patents to support global commercialization of the adipose-derived
mesenchymal stromal cell product Alofisel®, previously known as Cx601, a product candidate of Takeda, for the local treatment of
fistulae. The agreement includes the right for Takeda to grant sub-licenses to affiliates and third parties.
As part of the agreement, we received $5.9 million (€5.0 million) before withholding tax as a non-refundable upfront payment
and a further payment of $5.9 million (€5.0 million) before withholding tax 12 months after the patent license agreement date. We are
entitled to further payments up to €10.0 million when Takeda reaches certain product regulatory milestones. Additionally, we receive
single digit royalties on net sales of Alofisel®.
The agreement will continue in full force in each country (other than the United States) until the date upon which the last issued
claim of any licensed patent covering Alofisel® expires in such country (currently expected to be 2029) or, with respect to the United
States, until the later of (i) the date upon which the last issued claim of any licensed patent covering Alofisel® in the United States
expires (currently expected to be around 2031) or (ii) the expiration of the regulatory exclusivity period in the United States with an
agreed maximum term.
Either we or Takeda may terminate the agreement for any material breach that is not cured within 90 days after notice. We also
have the right to terminate the agreement with a written notice in the event that Takeda file a petition in bankruptcy or insolvency or
Takeda makes an assignment of substantially all of its assets for the benefit of its creditors.
Takeda has the right to terminate its obligation to pay royalties for net sales in a specific country if it is of the opinion that there
is no issued claim of any licensed patent covering Alofisel® in such country, subject to referral of the matter to the joint
oversight/cooperation committee established under the agreement if we disagree.
10.D
Exchange Controls
The Australian dollar is freely convertible into U.S. dollars. In addition, there are currently no specific rules or limitations
regarding the export from Australia of profits, dividends, capital or similar funds belonging to foreign investors, except that certain
payments to non-residents must be reported to the Australian Transaction Reports and Analysis Centre (“AUSTRAC”), which
monitors such transaction, and amounts on account of potential Australian tax liabilities may be required to be withheld unless a
relevant taxation treaty can be shown to apply.
Regulation of acquisition by foreign entities
Under Australian law, in certain circumstances foreign persons are prohibited from acquiring more than a limited percentage of
the shares in an Australian company without approval from the Australian Treasurer. These limitations are set forth in the Australian
Foreign Acquisitions and Takeovers Act 1975. These limitations are in addition to the more general overarching Takeovers
Prohibition of an acquisition of more than a 20% interest in a public company (in the absence of an applicable exception) under the
takeovers provisions of Australia's Corporations Act by any person whether foreign or otherwise.
Under the Foreign Acquisitions and Takeovers Act, as currently in effect, any foreign person, together with associates, or parties
acting in concert, is prohibited from acquiring 20% or more of the shares in any company having consolidated total assets of or that is
valued at A$266.0 million or more (or A$1,154.0 million or more in case of U.S. investors or investors from certain other countries).
No asset threshold applies in the case of foreign government investors. Different rules apply to sensitive industries (such as media,
telecommunications, and encryption and security technologies), companies owning land or that are agribusinesses. “Associates” is a
broadly defined term under the Foreign Acquisitions and Takeovers Act and includes in relation to any person:
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any relative of the person;
any person with whom the person is acting or proposes to act in concert;
any person with whom the person carries on a business in partnership;
any entity of which the person is a 'senior officer' (such as a director or executive);
if the person is an entity, any holding entity or any senior officer of the entity;
any entity whose senior officers are accustomed or obliged to act in accordance with the directions, instructions or wishes
of the person or if the person is an entity, its senior officers or vice versa;
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any corporation in which the person holds a 'substantial interest' (i.e., 20%) or any person holding a substantial interest in
the person if a corporation;
a trustee of a trust in which the person holds a substantial interest or if the person is the trustee of a trust, a person who
holds a substantial interest in the trust;
if the person is a foreign government, a separate government entity or a foreign government investor in relation to a
foreign country, any other person that is a foreign government, a separate government entity or foreign government
investor, in relation to that country.
The Australian Treasurer also has power in certain circumstances to make an order specifying that two or more persons are
associates.
In addition, a foreign person may not acquire shares in a company having consolidated total assets of or that is valued at A$266
million or more (or A$1,154 million or more in case of U.S. investors or investors from certain other countries) if, as a result of that
acquisition, the total holdings of all foreign persons and their associates will exceed 40% in aggregate without the approval of the
Australian Treasurer. If the necessary approvals are not obtained, the Treasurer may make an order requiring the acquirer to dispose of
the shares it has acquired within a specified period of time. The same rule applies if the total holdings of all foreign persons and their
associates already exceeds 40% and a foreign person (or its associate) acquires any further shares, including in the course of trading in
the secondary market of the ADSs. Different rules apply to government investors, and acquisitions of interests in sensitive business
acquisitions, agribusiness and land owning entities.
Each foreign person seeking to acquire holdings in excess of the above caps (including their associates, as the case may be)
would need to complete an application form setting out the proposal and relevant particulars of the acquisition/shareholding and pay
the relevant application fees. The Australian Treasurer then has 30 days to consider the application and make a decision. However, the
Australian Treasurer may extend the period by up to a further 90 days by publishing an interim order. The Australian Foreign
Investment Review Board, an Australian advisory board to the Australian Treasurer has provided a guideline titled Australia’s
Foreign Investment Policy which provides an outline of the policy. As for the risk associated with seeking approval, the policy
provides, among other things, that the Treasurer will reject an application if it is contrary to the national interest.
If the level of foreign ownership in Mesoblast exceeds 40% at any time, we would be considered a foreign person under the
Foreign Acquisitions and Takeovers Act. In such event, we would be required to obtain the approval of the Australian Treasurer for
our company, together with our associates, to acquire (i) more than 20% of an Australian company or business having total assets of,
or that is valued at, A$266 million or more; or (ii) any direct or indirect ownership in Australian land; or (iii) any ‘direct interest’ in
any agribusiness.
The percentage of foreign ownership in our company may also be included in determining the foreign ownership of any
Australian company or business in which we may choose to invest. Since we have no current plans for any such acquisition and do not
own any property, any such approvals required to be obtained by us as a foreign person under the Takeovers Act will not affect our
current or future ownership or lease of property in Australia.
Our Constitution does not contain any additional limitations on the right to hold or vote our securities by reason of being a non-
resident.
Australian law requires the transfer of shares in our company to be made in writing or electronically through the Clearing House
Electronic Sub-register System.
10.E
Taxation
The following summary of the material Australian and U.S. federal income tax consequences of an investment in our ADSs or
ordinary shares is based upon laws and relevant interpretations thereof in effect as of the date of this Form 20-F, all of which are
subject to change, possibly with retroactive effect. This summary does not deal with all possible tax consequences relating to an
investment in our ADSs or ordinary shares, such as the tax consequences under U.S. state, local and other tax laws other than
Australian and U.S. federal income tax laws.
Certain Material U.S. Federal Income Tax Considerations to U.S. Holders
The following summary describes certain material U.S. federal income tax consequences to U.S. holders (as defined below) of
the ownership and disposition of our ordinary shares and ADSs as of the date hereof. Except where noted, this summary deals only
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with our ordinary shares or ADSs acquired and held as capital assets within the meaning of Section 1221 of the Internal Revenue Code
of 1986, as amended (the “Code”). This section does not discuss the tax consequences to any particular holder, nor any tax
considerations that may apply to holders subject to special tax rules, such as:
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banks, insurance companies, regulated investment companies and real estate investment trusts;
financial institutions;
individual retirement and other tax-deferred accounts;
certain former U.S. citizens or long-term residents;
brokers or dealers in securities or currencies;
traders that elect to use a mark-to-market method of accounting;
partnerships and other entities treated as partnership or pass through entities for U.S. federal income tax purposes, and
partners or investors in such entities;
tax-exempt organizations (including private foundations);
persons that may have been subject to the alternative minimum tax;
persons that hold or dispose of ordinary shares or ADSs as a position in a straddle or as part of a hedging, constructive
sale, conversion or other integrated transaction;
persons that have a functional currency other than the U.S. dollar;
persons that own (directly, indirectly or constructively) 10% or more of the vote or value of our equity;
persons subject to special tax accounting rules as a result of any item of gross income with respect to ordinary shares or
ADSs being taken into account in an applicable financial statement;
persons who acquire ordinary shares or ADSs pursuant to the exercise of any employee share option or otherwise as
compensation; or
persons that are not U.S. holders (as defined below).
In this section, a “U.S. holder” means a beneficial owner of ordinary shares or ADSs, other than a partnership or other entity
treated as a partnership for U.S. federal income tax purposes, that is, for U.S. federal income tax purposes:
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an individual who is a citizen or resident of the United States (for U.S. federal income tax purposes);
a corporation (or other entity treated as a corporation for U.S. federal income tax purposes) created or organized in or
under the laws of the United States or any state thereof or the District of Columbia;
an estate the income of which is includable in gross income for U.S. federal income tax purposes regardless of its source;
or
a trust (i) the administration of which is subject to the primary supervision of a court in the United States and for which
one or more U.S. persons have the authority to control all substantial decisions or (ii) that has an election in effect under
applicable U.S. income tax regulations to be treated as a U.S. person.
The discussion below is based upon the provisions of the Code, and the U.S. Treasury regulations, rulings and judicial decisions
thereunder as of the date hereof, and such authorities may be replaced, revoked or modified, possibly with retroactive effect, so as to
result in U.S. federal income tax consequences different from those discussed below. In addition, this summary is based, in part, upon
the terms of the deposit agreement and assumes that the deposit agreement, and all other related agreements, will be performed in
accordance with their terms.
If a partnership or an entity or arrangement treated as a partnership for U.S. federal income tax purposes acquires, owns or
disposes of ordinary shares or ADSs, the U.S. federal income tax treatment of a partner generally will depend on the status of the
partner and the activities of the partnership. Partners of partnerships that acquire, own or dispose of ordinary shares or ADSs should
consult their tax advisors.
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You are urged to consult your own tax advisor with respect to the U.S. federal, as well as state, local and non-U.S., tax
consequences to you of acquiring, owning and disposing of ordinary shares or ADSs in light of your particular circumstances,
including the possible effects of changes in U.S. federal income and other tax laws and the effects of any tax treaties.
ADSs
Assuming the deposit agreement and all other related agreements will be performed in accordance with their terms, a U.S.
holder of ADSs will be treated as the beneficial owner for U.S. federal income tax purposes of the underlying shares represented by
the ADSs. The U.S. Treasury has expressed concerns that parties to whom American depositary shares are released before shares are
delivered to the depositary, or intermediaries in the chain of ownership between holders of American depositary shares and the issuer
of the security underlying the American depositary shares, may be taking actions that are inconsistent with claiming foreign tax credits
by holders of American depositary shares. These actions would also be inconsistent with claiming the reduced rate of tax, described
below, applicable to dividends received by certain non-corporate holders. Accordingly, the creditability of any foreign taxes and the
availability of the reduced tax rate for dividends received by certain non-corporate U.S. holders, each described below, could be
affected by actions taken by such parties or intermediaries.
Distributions
Subject to the passive foreign investment company, or PFIC, rules discussed below, U.S. holders generally will include as
dividend income the U.S. dollar value of the gross amount of any distributions of cash or property (without deduction for any
withholding tax), other than certain pro rata distributions of ordinary shares, with respect to ordinary shares or ADSs to the extent the
distributions are made from our current or accumulated earnings and profits, as determined for U.S. federal income tax purposes. A
U.S. holder will include the dividend income on the day actually or constructively received: (i) by the holder, in the case of ordinary
shares, or (ii) by the depositary, in the case of ADSs. To the extent, if any, that the amount of any distribution by us exceeds our
current and accumulated earnings and profits, as so determined, the excess will be treated first as a tax-free return of the U.S. holder’s
tax basis in the ordinary shares or ADSs and thereafter as capital gain. Notwithstanding the foregoing, we do not intend to determine
our earnings and profits on the basis of U.S. federal income tax principles. Consequently, any distributions generally will be reported
as dividend income for U.S. information reporting purposes. See “—Backup Withholding Tax and Information Reporting
Requirements” below. Dividends paid by us will not be eligible for the dividends-received deduction generally allowed to U.S.
corporate shareholders.
The U.S. dollar amount of dividends received by an individual, trust or estate with respect to the ordinary shares or ADSs will
be subject to taxation at preferential rates if the dividends are “qualified dividends.” Dividends paid on ordinary shares or ADSs will
be treated as qualified dividends if (i)(a) we are eligible for the benefits of a comprehensive income tax treaty with the United States
that the Secretary of the Treasury of the United States determines is satisfactory for this purpose and includes an exchange of
information program or (b) the dividends are with respect to ordinary shares (or ADSs in respect of such shares) which are readily
tradable on a U.S. securities market; (ii) certain holding period requirements are met; and (iii) we are not classified as a PFIC for the
taxable year in which the dividend is paid or for the preceding taxable year. The Agreement between the Government of the United
States of America and the Government of Australia for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with
Respect to Taxes on Income, or the Treaty, has been approved for the purposes of the qualified dividend rules, and we expect to
qualify for benefits under the Treaty. In addition, our ADSs are listed on the Nasdaq Global Select Market, and as such U.S. Treasury
Department guidance indicates that our ADSs will be readily tradable on an established U.S. securities market. Thus, we believe that
as long as we are not a PFIC, dividends we pay generally should be eligible for the preferential tax rates on qualified dividends.
However, the determination of whether a dividend qualifies for the preferential tax rates must be made at the time the dividend is paid.
U.S. holders should consult their own tax advisors regarding the availability of the preferential tax rates on dividends.
Includible distributions paid in Australian dollars, including any Australian withholding taxes, will be included in the gross
income of a U.S. holder in a U.S. dollar amount calculated by reference to the spot exchange rate in effect on the date of actual or
constructive receipt, regardless of whether the Australian dollars are converted into U.S. dollars at that time. If Australian dollars are
converted into U.S. dollars on the date of actual or constructive receipt, the tax basis of the U.S. holder in those Australian dollars will
be equal to their U.S. dollar value on that date and, as a result, a U.S. holder generally should not be required to recognize any foreign
currency exchange gain or loss. If Australian dollars so received are not converted into U.S. dollars on the date of receipt, the U.S.
holder will have a basis in the Australian dollars equal to their U.S. dollar value on the date of receipt. Any foreign currency exchange
gain or loss on a subsequent conversion or other disposition of the Australian dollars generally will be treated as ordinary income or
loss to such U.S. holder and generally will be income or loss from sources within the United States for foreign tax credit limitation
purposes.
Dividends received by a U.S. holder with respect to ordinary shares (or ADSs in respect of such shares) will be treated as
foreign source income, which may be relevant in calculating the holder’s foreign tax credit limitation. The limitation on foreign taxes
eligible for credit is calculated separately with respect to specific classes of income. For this purpose, dividends distributed by us with
respect to ADSs or ordinary shares will generally constitute “passive category income” but could, in the case of certain U.S. holders,
constitute “general category income.”
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Subject to certain complex limitations, including the PFIC rules discussed below, a U.S. holder generally will be entitled, at
such holder's option, to claim either a credit against such holder's U.S. federal income tax liability or a deduction in computing such
holder's U.S. federal taxable income in respect of any Australian taxes withheld. If a U.S. holder elects to claim a deduction, rather
than a foreign tax credit, for Australian taxes withheld for a particular taxable year, the election will apply to all foreign taxes paid or
accrued by or on behalf of the U.S. holder in the particular taxable year.
The availability of the foreign tax credit and the application of the limitations on its availability are fact specific and are subject
to complex rules. You are urged to consult your own tax advisor as to the consequences of Australian withholding taxes and the
availability of a foreign tax credit or deduction. See “—Australian Tax Considerations Australian—Income Tax—Taxation of
Dividends” below.
Sale, Exchange or Other Disposition of Ordinary Shares or ADSs
Subject to the PFIC rules discussed below, a U.S. holder generally will, for U.S. federal income tax purposes, recognize capital
gain or loss, if any, on a sale, exchange or other disposition of ordinary shares or ADSs equal to the difference between the amount
realized on the disposition and the U.S. holder’s tax basis (in U.S. dollars) in the ordinary shares or ADSs. This recognized gain or
loss will generally be long-term capital gain or loss if the U.S. holder has held the ordinary shares or ADSs for more than one year.
Generally, for U.S. holders who are individuals (as well as certain trusts and estates), long-term capital gains are subject to U.S.
federal income tax at preferential rates. For foreign tax credit limitation purposes, gain or loss recognized upon a disposition generally
will be treated as from sources within the United States. The deductibility of capital losses is subject to limitations for U.S. federal
income tax purposes.
You should consult your own tax advisor regarding the tax consequences if a foreign tax is imposed on a disposition of ADSs or
ordinary shares, including availability of a foreign tax credit or deduction in respect of any Australian tax imposed on a sale or other
disposition of ordinary shares or ADSs. See “—Australian Tax Considerations—Australian Income Tax—Tax on Sales or Other
Dispositions of Shares—Capital Gains Tax.”
Passive Foreign Investment Company
As a non-U.S. corporation, we will be a PFIC for any taxable year if either: (i) 75% or more of our gross income for the taxable
year is passive income (such as certain dividends, interest, rents or royalties and certain gains from the sale of shares and securities or
commodities transactions, including amounts derived by reason of the temporary investment of funds raised in offerings of our
ordinary shares or ADSs); or (ii) the average quarterly value of our gross assets during the taxable year that produce passive income or
are held for the production of passive income is at least 50% of the value of our total assets. For purposes of the PFIC asset test,
passive assets generally include any cash, cash equivalents and cash invested in short-term, interest bearing debt instruments or bank
deposits that are readily convertible into cash. If we own at least 25% (by value) of the stock of another corporation, we will be
treated, for purposes of the PFIC income and asset tests, as owning our proportionate share of the other corporation’s assets and
receiving our proportionate share of the other corporation’s income.
We do not believe that we were a PFIC for the taxable year ending June 30, 2021. However, if there is a change in the type or
composition of our gross income, or our actual business results do not match our projections, it is possible that we may become a
PFIC in future taxable years. Investors should be aware that our gross income for purposes of the PFIC income test depends on the
receipt of Australian research and development tax incentive credits and other revenue, and there can be no assurances that such tax
incentive credit programs will not be revoked or modified, that we will continue to conduct our operations in the manner necessary to
be eligible for such incentives or that we will receive other gross income that is not considered passive for purposes of the PFIC
income test. The value of our assets for purposes of the PFIC asset test will generally be determined by reference to our market
capitalization, which may fluctuate. The composition of our income and assets will also be affected by how, and how quickly, we
spend the cash raised in offerings of our ordinary shares or ADSs. Under circumstances where our gross income from activities that
produce passive income significantly increases relative to our gross income from activities that produce non-passive income or where
we decide not to deploy significant amounts of cash for active purposes, our risk of becoming classified as a PFIC may substantially
increase. Since a separate factual determination as to whether we are or have become a PFIC must be made each year (after the close
of such year), we cannot assure you that we will not be or become a PFIC in the current year or any future taxable year. There can be
no assurance that we will not be a PFIC for any taxable year, as PFIC status is determined each year and depends on the composition
of our income and assets and the value of our assets in such year. If we are a PFIC for any taxable year, upon request, we intend to
provide U.S. holders with the information necessary to make and maintain a “Qualified Electing Fund” election, as described below.
Default PFIC Rules
If we are a PFIC for any taxable year during which you own our ordinary shares or ADSs, unless you make the mark-to-market
election or the Qualified Electing Fund election described below, you will generally be (and remain) subject to additional taxes and
interest charges, regardless of whether we remain a PFIC in any subsequent taxable year, (i) on certain “excess distributions” we may
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make; and (ii) on any gain realized on the disposition or deemed disposition of your ordinary shares or ADSs. Distributions in respect
of your ordinary shares (or ADSs in respect of such shares) during the taxable year will generally constitute “excess” distributions if,
in the aggregate, they exceed 125% of the average amount of distributions in respect of your ordinary shares (or ADSs) over the three
preceding taxable years or, if shorter, the portion of your holding period before such taxable year.
To compute the tax on “excess” distributions or any gain: (i) the “excess” distribution or the gain will be allocated ratably to
each day in your holding period for the ADSs or the ordinary shares; (ii) the amount allocated to the current taxable year and any
taxable year before we became a PFIC will be taxed as ordinary income in the current year; (iii) the amount allocated to other taxable
years will be taxable at the highest applicable marginal rate in effect for that year; and (iv) an interest charge at the rate for
underpayment of taxes will be imposed with respect to any portion of the “excess” distribution or gain described under (iii) above that
is allocated to such other taxable years. In addition, if we are a PFIC or, with respect to a particular U.S. holder, we are treated as a
PFIC for the taxable year in which the distribution was paid or the prior taxable year, no distribution that you receive from us will
qualify for taxation at the preferential rate for non-corporate holders discussed in “—Distributions” above. You should consult with
your own tax advisor regarding the application of the default PFIC rules based on your particular circumstances.
If we are a PFIC for any taxable year during which a U.S. holder holds our ADSs or ordinary shares and any of our non-U.S.
subsidiaries is also a PFIC (i.e., a lower-tier PFIC), such U.S. holder would be treated as owning a proportionate amount (by value) of
the shares of the lower-tier PFIC and would be subject to the rules described above on certain distributions by the lower-tier PFIC and
our disposition of shares of the lower-tier PFIC, even though such U.S. holder would not receive the proceeds of those distributions or
dispositions. You should consult with your own tax advisor regarding the application to you of the PFIC rules to any of our
subsidiaries if we are a PFIC.
Mark-to-Market Election
If we are a PFIC for any taxable year during which you own our ADSs or ordinary shares, you will be able to avoid the rules
applicable to “excess” distributions or gains described above if the ordinary shares or ADSs are “marketable” and you make a timely
“mark-to-market” election with respect to your ordinary shares or ADSs. The ordinary shares or ADSs will be “marketable” stock as
long as they remain regularly traded on a national securities exchange, such as the Nasdaq Global Select Market, or a foreign
securities exchange regulated by a governmental authority of the country in which the market is located and which meets certain
requirements, including that the rules of the exchange effectively promote active trading of listed stocks. If such stock is traded on
such a qualified exchange or other market, such stock generally will be “regularly traded” for any calendar year during which such
stock is traded, other than in de minimis quantities, on at least 15 days during each calendar quarter, but no assurances can be given in
this regard. Our ordinary shares are traded on the ASX, which may qualify as an eligible foreign securities exchange for this purpose.
If you are eligible to make a “mark-to-market” election with respect to our ordinary shares or ADSs and you make this election
in a timely fashion, you will generally recognize as ordinary income or ordinary loss the difference between the fair market value of
your ordinary shares or ADSs on the last day of any taxable year and your adjusted tax basis in the ordinary shares or ADSs. Any
ordinary income resulting from this election will generally be taxed at ordinary income rates. Any ordinary losses will be deductible
only to the extent of the net amount of previously included income as a result of the mark-to-market election, if any. Your adjusted tax
basis in the ordinary shares or ADSs will be adjusted to reflect any such income or loss. Any gain recognized on the sale or other
disposition of your ordinary shares or ADSs in a year when we are a PFIC will be treated as ordinary income, and any loss will be
treated as an ordinary loss (but only to the extent of the net amount previously included as ordinary income as a result of the mark-to-
market election).
Because a mark-to-market election cannot be made for any lower-tier PFICs that we may own, a U.S. holder may continue to be
subject to the PFIC rules with respect to such holder's indirect interest in any investments held by us that are treated as an equity
interest in a PFIC for U.S. federal income tax purposes, including shares in any of our subsidiaries that are treated as PFICs.
You should consult with your own tax advisor regarding the applicability and potential advantages and disadvantages to you of
making a “mark-to-market” election with respect to your ordinary shares or ADSs if we are or become a PFIC, including the tax issues
raised by lower-tier PFICs that we may own and the procedures for making such an election.
QEF Election
Alternative rules to those set forth under “Default PFIC Rules” above apply if an election is made to treat us as a “Qualified
Electing Fund,” or QEF, under Section 1295 of the Code. A QEF election is available only if a U.S. holder receives an annual
information statement from us setting forth such holder's pro rata share of our ordinary earnings and net capital gains, as calculated for
U.S. federal income tax purposes.
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Upon request from a U.S. holder, we will endeavor to provide to the U.S. holder within 90 days after the request an annual
information statement, in order to enable the U.S. holder to make and maintain a QEF election for us or for any of our subsidiaries that
is or becomes a PFIC. However, there is no assurance that we will have timely knowledge of our or our subsidiaries’ status as a PFIC
in the future or of the required information to be provided. You should consult your own tax advisor regarding the availability and tax
consequences of a QEF election with respect to the ordinary shares or ADSs or with respect to any lower-tier PFIC that we may own
under your particular circumstances.
Reporting
If we are a PFIC for any taxable year during which you own our ordinary shares or ADSs, as a U.S. holder, you will generally
be required to file IRS Form 8621 on an annual basis and other reporting requirements may apply. The PFIC rules are complex and
you should consult with your own tax advisor regarding whether we or any of our subsidiaries are a PFIC, the tax consequences of any
elections that may be available to you, and how the PFIC rules may affect the U.S. federal income tax consequences of the receipt,
ownership, and disposition of our ordinary shares or ADSs.
Tax on Net Investment Income
Certain non-corporate U.S. holders will be subject to a 3.8% tax on the lesser of (i) the U.S. holder’s “net investment income”
for the relevant taxable year; and (ii) the excess of the U.S. holder’s modified adjusted gross income for the taxable year over a certain
threshold. A U.S. holder’s net investment income will generally include dividends received on the ordinary shares or ADSs and net
gains from the disposition of ordinary shares or ADSs, unless such dividend income or net gains are derived in the ordinary course of
the conduct of a trade or business (other than a trade or business that consists of certain passive or trading activities). A U.S. holder
that is an individual, estate or trust should consult the holder’s tax advisor regarding the applicability of the tax on net investment
income to the holder’s dividend income and gains in respect of the holder’s investment in the ordinary shares or ADSs.
Backup Withholding Tax and Information Reporting Requirements
U.S. backup withholding tax and information reporting requirements generally apply to payments to non-corporate holders of
ordinary shares or ADSs. Information reporting will apply to payments of dividends on, and to proceeds from the disposition of,
ordinary shares or ADSs by a paying agent within the United States to a U.S. holder, other than U.S. holders that are exempt from
information reporting and properly certify their exemption. A paying agent within the United States will be required to withhold at the
applicable statutory rate, currently 24%, in respect of any payments of dividends on, and the proceeds from the disposition of, ordinary
shares or ADSs within the United States to a U.S. holder (other than U.S. holders that are exempt from backup withholding and
properly certify their exemption) if the holder fails to furnish its correct taxpayer identification number or otherwise fails to comply
with applicable backup withholding requirements. U.S. holders who are required to establish their exempt status generally must
provide a properly completed IRS Form W-9.
Backup withholding is not an additional tax. Amounts withheld as backup withholding may be credited against a U.S. holder’s
U.S. federal income tax liability. A U.S. holder generally may obtain a refund of any amounts withheld under the backup withholding
rules in excess of such holder’s U.S. federal income tax liability by filing the appropriate claim for refund with the IRS in a timely
manner and furnishing any required information.
Certain U.S. holders may be required to report (on IRS Form 8938) information with respect to such holder’s interest in
“specified foreign financial assets” (as defined in Section 6038D of the Code), including stock of a non-U.S. corporation that is not
held in an account maintained by a U.S. “financial institution”. Persons who are required to report specified foreign financial assets
and fail to do so may be subject to substantial penalties. U.S. holders are urged to consult their own tax advisors regarding foreign
financial asset reporting obligations and their possible application to the holding of ordinary shares or ADSs.
The discussion above is a general summary only. It is not intended to constitute a complete analysis of all tax considerations
applicable to an investment in our ADSs or ordinary shares. You should consult with your own tax advisor concerning the tax
consequences to you of an investment in our ADSs or ordinary shares in light of your particular circumstances.
Australian Tax Considerations
In this section, we discuss the material Australian income tax, stamp duty and goods and services tax considerations related to
the acquisition, ownership and disposal by the absolute beneficial owners of the ordinary shares or ADSs. It is based upon existing
Australian tax law as of the date of this annual report, which is subject to change, possibly retrospectively. This discussion does not
address all aspects of Australian tax law which may be important to particular investors in light of their individual investment
circumstances, such as shares held by investors subject to special tax rules (for example, financial institutions, insurance companies or
tax exempt organizations). In addition, this summary does not discuss any foreign or state tax considerations, other than stamp duty
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and goods and services tax. Prospective investors are urged to consult their tax advisors regarding the Australian and foreign income
and other tax considerations of the acquisition, ownership and disposition of the shares. This summary is based upon the premise that
the holder is not an Australian tax resident and is not carrying on business in Australia through a permanent establishment (referred to
as a “Foreign Shareholder” in this summary).
Australian Income Tax
Nature of ADSs for Australian Taxation Purposes
Ordinary shares represented by ADSs held by a U.S. holder will be treated for Australian taxation purposes as held under a
“bare trust” for such holder. Consequently, the underlying ordinary shares will be regarded as owned by the ADS holder for Australian
income tax and capital gains tax purposes. Dividends paid on the underlying ordinary shares will also be treated as dividends paid to
the ADS holder, as the person beneficially entitled to those dividends. Therefore, in the following analysis we discuss the tax
consequences to non-Australian resident holders of ordinary shares which, for Australian taxation purposes, will be the same as to
U.S. holders of ADSs.
Taxation of Dividends
Australia operates a dividend imputation system under which dividends may be declared to be “franked” to the extent of tax
paid on company profits. Fully franked dividends are not subject to dividend withholding tax. Dividends payable to non-Australian
resident shareholders that are not operating from an Australian permanent establishment, or Foreign Shareholders, will be subject to
dividend withholding tax, to the extent the dividends are not foreign (i.e., non-Australian) sourced and declared to be conduit foreign
income, or CFI, and are unfranked. Dividend withholding tax will be imposed at 30%, unless a shareholder is a resident of a country
with which Australia has a double taxation agreement and qualifies for the benefits of the treaty. Under the provisions of the current
Double Taxation Convention between Australia and the United States, the Australian tax withheld on unfranked dividends that are not
CFI paid by us to which a resident of the United States is beneficially entitled is limited to 15%.
If a company that is a non-Australian resident shareholder directly owns a 10% or more interest, the Australian tax withheld on
unfranked dividends (that are not CFI) paid by us to which a resident of the United States is beneficially entitled is limited to 5%. In
limited circumstances the rate of withholding can be reduced to zero.
Tax on Sales or Other Dispositions of Shares—Capital Gains Tax
Foreign Shareholders will not be subject to Australian capital gains tax on the gain made on a sale or other disposal of our
ordinary shares, unless they, together with associates, hold 10% or more of our issued capital, at the time of disposal or for 12 months
of the last 2 years prior to disposal.
Foreign Shareholders who own a 10% or more interest would be subject to Australian capital gains tax if more than 50% of our
assets held directly or indirectly, determined by reference to market value, consists of Australian real property (which includes land
and leasehold interests) or Australian mining, quarrying or prospecting rights. The Double Taxation Convention between the United
States and Australia is unlikely to limit the amount of this taxable gain. Australian capital gains tax applies to net capital gains of
Foreign Shareholders at the Australian tax rates for non-Australian residents, which start at a marginal rate of 32.5%. Net capital gains
are calculated after reduction for capital losses, which may only be offset against capital gains.
The 50% capital gains tax discount is not available to non-Australian residents on gains accrued after May 8, 2012. Companies
are not entitled to a capital gains tax discount.
Broadly, where there is a disposal of certain taxable Australian property, the purchaser will be required to withhold and remit to
the Australian Taxation Office (“ATO”) 12.50% of the proceeds from the sale. A transaction is excluded from the withholding
requirements in certain circumstances, including where the value of the taxable Australian property is less than A$750,000, the
transaction is an on-market transaction conducted on an approved stock exchange, a securities lending, or the transaction is conducted
using a broker operated crossing system. There is also an exception to the requirement to withhold where the Commissioner issues a
clearance certificate which broadly certifies that the vendor is not a foreign person. The Foreign Shareholder may be entitled to
receive a tax credit for the tax withheld by the purchaser which they may claim in their Australian income tax return.
Tax on Sales or Other Dispositions of Shares—Shareholders Holding Shares on Revenue Account
Some Foreign Shareholders may hold ordinary shares on revenue rather than on capital account for example, share traders.
These shareholders may have the gains made on the sale or other disposal of the ordinary shares included in their assessable income
under the ordinary income provisions of the income tax law, if the gains are sourced in Australia.
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Foreign Shareholders assessable under these ordinary income provisions in respect of gains made on ordinary shares held on
revenue account would be assessed for such gains at the Australian tax rates for non-Australian residents, which start at a marginal
rate of 32.5%. Some relief from Australian income tax may be available to such non-Australian resident shareholders under the
Double Taxation Convention between the United States and Australia.
To the extent an amount would be included in a Foreign Shareholder’s assessable income under both the capital gains tax
provisions and the ordinary income provisions, the capital gain amount would generally be reduced, so that the shareholder would not
be subject to double tax on any part of the income gain or capital gain.
The comments above in “Tax on Sales or Other Dispositions of Shares—Capital Gains Tax” regarding a purchaser being
required to withhold 12.5% tax on the acquisition of certain taxable Australian property equally applies where the disposal of the
Australian real property asset by a foreign resident is likely to generate gains on revenue account, rather than a capital gain.
Dual Residency
If a shareholder were a resident of both Australia and the United States under those countries’ domestic taxation laws, that
shareholder may be subject to tax as an Australian resident. If, however, the shareholder is determined to be a U.S. resident for the
purposes of the Double Taxation Convention between the United States and Australia, the Australian tax may be subject to limitation
by the Double Taxation Convention. Shareholders should obtain specialist taxation advice in these circumstances.
Australian Death Duty
Australia does not have estate or death duties. As a general rule, no capital gains tax liability is realized upon the inheritance of a
deceased person’s ordinary shares. The disposal of inherited ordinary shares by beneficiaries may, however, give rise to a capital gains
tax liability if the gain falls within the scope of Australia’s jurisdiction to tax (as discussed above).
Stamp Duty
No Australian stamp duty is payable by Australian residents or non-Australian residents on the issue, transfer and/or surrender
of the ADSs or the ordinary shares in Mesoblast, provided that all of the ADSs and ordinary shares in Mesoblast are listed on Nasdaq
and ASX and the shares issued, transferred and/or surrendered do not represent 90% or more of the issued shares in Mesoblast.
Goods and Services Tax
The supply of ADSs and/or ordinary shares in Mesoblast will not be subject to Australian goods and services tax.
10.F
Dividends and Paying Agents
Not applicable.
10.G
Statement by Experts
Not applicable.
10.H
Documents on Display
Any statement in this Form 20-F about any of our contracts or other documents is not necessarily complete. If the contract or
document is filed as an exhibit to the Form 20-F the contract or document is deemed to modify the description contained in this Form
20-F. You must review the exhibits themselves for a complete description of the contract or document.
You may review a copy of our filings with the SEC, as well as other information furnished to the SEC, including exhibits and
schedules filed with it, at the SEC’s public reference room at 100 F Street, N.E., Room 1580, Washington, D.C. 20549. Please call the
SEC at 1-800-SEC-0330 for further information. In addition, the SEC maintains a website at http://www.sec.gov that contains reports
and other information regarding issuers that file electronically with the SEC. These SEC filings are also available to the public from
commercial document retrieval services.
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We are required to file or furnish reports and other information with the SEC under the Securities Exchange Act of 1934 and
regulations under that act. As a foreign private issuer, we are exempt from the rules under the Exchange Act prescribing the form and
content of proxy statements and our officers, directors and principal shareholders are exempt from the reporting and short swing profit
recovery provisions contained in Section 16 of the Exchange Act.
10.I
Subsidiary Information
For information about our subsidiaries, see “Item 18. Financial Statements – Note 12.”
Item 11. Quantitative and Qualitative Disclosures about Market Risk
For information about our exposure to market risk and how we manage this risk, see “Item 18. Financial Statements – Note 10.”
Item 12. Description of Securities Other than Equity Securities
12.A
Debt Securities
Not applicable.
12.B
Warrants and Rights
Not applicable.
12.C
Other Securities
Not applicable.
12.D
American Depositary Shares
Fees Payable by ADR Holders
Holders of our ADRs may have to pay our ADS depositary, JPMorgan Chase Bank N.A. (JPMorgan), fees or charges up to the
amounts described in the following table:
Persons depositing or withdrawing ordinary shares or ADS
holders must pay:
$5.00 (or less) per 100 ADSs (or portion of 100
ADSs)
$0.05 (or less) per ADS
$1.50 per ADR
$0.05 (or less) per ADS per calendar year
Fees Payable by the Depositary to the Issuer
Description of service
• Issuance of ADSs, including issuances pursuant to a
deposits of shares, share or rights distributions, stock
dividend, stock split, merger or any other transactions
affecting the issuance of ADSs
• Cancellation of ADSs for the purpose of withdrawal
of deposited securities
• Cash distribution to ADS holders
• Transfers of ADRs
• Administrative services performed by the depositary
From time to time, the depositary may make payments to us to reimburse and/or share revenue from the fees collected from
ADS holders, or waive fees and expenses for services provided, generally relating to costs and expenses arising out of establishment
and maintenance of the ADS program. In performing its duties under the deposit agreement, the depositary may use brokers, dealers
or other service providers that are affiliates of the depositary and that may earn or share fees or commissions.
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Item 13. Defaults, Dividend Arrearages and Delinquencies
Not applicable.
PART II
Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds
Not applicable.
Item 15. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the
effectiveness of our disclosure controls and procedures as of June 30, 2021. “Disclosure controls and procedures,” as defined in Rules
13a-15(e) and 15d-15(e) under the Exchange Act, are designed to ensure that information required to be disclosed by a company in the
reports that it files or submits under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods
specified in the Securities and Exchange Commission’s rules and forms and (ii) accumulated and communicated to the company's
management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions
regarding required disclosure.
Based on the evaluation of our disclosure controls and procedures, our Chief Executive Officer and Chief Financial Officer
concluded that our disclosure controls and procedures were effective as of June 30, 2021.
Management’s Report on Internal Controls over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in
Rule 13a-15(f) and 15d-15(f) under the Exchange Act. Our management conducted an assessment of the effectiveness of our internal
control over financial reporting as of June 30, 2021 based on the criteria set forth in Internal Control-Integrated Framework (2013)
issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on the assessment, our management has
concluded that its internal control over financial reporting was effective as of June 30, 2021.
Changes in Internal Control over Financial Reporting
There were no changes to our internal control over financial reporting that occurred during the period covered by this Form 20-F
that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on Controls
Our disclosure controls and procedures and
to provide
reasonable assurance of achieving the desired control objectives. Our management recognizes that any control system, no
matter how well designed and operated, is based upon certain judgments and assumptions and cannot provide absolute assurance that
its objectives will be met. Similarly, an evaluation of controls cannot provide absolute assurance that misstatements due to error or
fraud will not occur or that all control issues and instances of fraud, if any, have been detected.
internal control over financial reporting are designed
Item 16A. Audit Committee Financial Expert
The Board of Directors of Mesoblast Ltd has determined that Michael Spooner possesses specific accounting and
financial management expertise and is an Audit Committee Financial Expert as defined by the SEC. The Board of Directors
has also determined that Donal O’Dwyer and Joseph Swedish, members of the Audit and Risk Management Committee, have
sufficient experience and ability in finance and compliance matters to enable them to adequately discharge their responsibilities. All
members of the Audit and Risk Management Committee are “independent” according to the listing standards of the Nasdaq Global
Select Market.
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Item 16B. Code of Ethics
Our Code of Conduct covers conflicts of interest, confidentiality, fair dealing, protection of assets, compliance with laws and
regulations, whistle blowing, security trading and commitments to stakeholders. In summary, the code requires that at all times all
Company personnel act with the utmost integrity, objectivity and in compliance with the letter and the spirit of the law and Company
policies. This document is accessible on our internet website at: http://www.mesoblast.com/company/corporate-governance/code-of-
conduct-and-values.
Item 16C. Principal Accountant Fees and Services
Pre-Approval of Audit and Non-Audit Services
The Audit and Risk Management Committee’s pre-approval is required for all services provided by PwC. These services may
include audit services, audit-related services, tax services and permissible non-audit services, and are subject to a specific budget. The
Audit and Risk Management Committee uses a combination of two approaches – general pre-approval and specific pre-approval – in
considering whether particular services or categories of services are consistent with the SEC’s rules on auditor independence. Under
general pre-approval proposed services may be pre-approved without consideration of specific case-by-case services.
Audit and Non-Audit Services Fees
See “Item 18. Financial Statements – Note 18”. For the purpose of SEC classification, there were no audit-related, tax or other
fees that were paid or payable to PwC that were not pre-approved by the Audit and Risk Management Committee during the years
ended June 30, 2021 and 2020.
Item 16D. Exemptions from the Listing Standards for Audit Committees
Not applicable.
Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers
Not applicable.
Item 16F. Change in Registrant’s Certifying Accountant
Not applicable.
Item 16G. Corporate Governance
Under Nasdaq Stock Market Rule 5615(a)(3), foreign private issuers, such as our company, are permitted to follow certain home
country corporate governance practices instead of certain provisions of the Nasdaq Stock Market Rules. For example, we may follow
home country practice with regard to certain corporate governance requirements, such as the composition of the board of directors and
quorum requirements applicable to shareholders’ meetings. In addition, we may follow home country practice instead of the Nasdaq
Stock Market Rules requirement to hold executive sessions and to obtain shareholder approval prior to the issuance of securities in
connection with certain acquisitions or private placements of securities. Further, we may follow home country practice instead of the
Nasdaq Stock Market Rules requirement to obtain shareholder approval prior to the establishment or amendment of certain share
option, purchase or other compensation plans. A foreign private issuer that elects to follow a home country practice instead of any
Nasdaq rule must submit to Nasdaq, in advance, a written statement from an independent counsel in such issuer’s home country
certifying that the issuer’s practices are not prohibited by the home country’s laws. We submitted such a written statement to Nasdaq.
Other than as set forth below, we currently intend to comply with the corporate governance listing standards in the Nasdaq
Stock Market Rules to the extent possible under Australian law. However, we may choose to change such practices to follow home
country practice in the future.
The Nasdaq Stock Market Rules require that a listed company specify that the quorum for any meeting of the holders of share
capital be at least 33 1/3% of the outstanding shares of the company’s common voting stock. We follow our home country practice,
rather than complying with this rule. Consistent with Australian law, our bylaws do not require a quorum of at least 33 1/3% of the
issued voting shares of Mesoblast for any general meeting of its shareholders. Our constitution provides that a quorum for a general
meeting of our shareholders constitutes two shareholders present in person, by proxy, by attorney, or, where the shareholders is a body
corporate, by representative. This provision and our practice of holding meetings with this quorum are not prohibited by the ASX
Listing Rules or any other Australian law.
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Item 16H. Mine Safety Disclosure
Not applicable.
PART III
Item 17.
Financial Statements
See “Item 18. Financial Statements”.
Item 18.
Financial Statements
The following financial statements are filed as part of this annual report on Form 20-F.
Australian Disclosure Requirements
All press releases, financial reports and other information are available on our website: www.mesoblast.com
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Auditor’s Independence Declaration
As lead auditor for the audit of Mesoblast Limited for the year ended 30 June 2021, I declare that to
the best of my knowledge and belief, there have been:
(a) no contraventions of the auditor independence requirements of the Corporations Act 2001 in
relation to the audit; and
(b) no contraventions of any applicable code of professional conduct in relation to the audit.
This declaration is in respect of Mesoblast Limited and the entities it controlled during the period.
Sam Lobley
Partner
PricewaterhouseCoopers
Melbourne
31 August 2021
PricewaterhouseCoopers, ABN 52 780 433 757
2 Riverside Quay, SOUTHBANK VIC 3006, GPO Box 1331 MELBOURNE VIC 3001
T: +61 3 8603 1000, F: +61 3 8603 1999, www.pwc.com.au
Liability limited by a scheme approved under Professional Standards Legislation.
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139
Index to Financial Statements
Consolidated Income Statement ..........................................................................................................................................................
Consolidated Statement of Comprehensive Income............................................................................................................................
Consolidated Statement of Changes in Equity ....................................................................................................................................
Consolidated Balance Sheet ................................................................................................................................................................
Consolidated Statement of Cash Flows ...............................................................................................................................................
Notes to Consolidated Financial Statements........................................................................................................................................
141
142
143
144
145
146
140
Mesoblast Limited
Consolidated Income Statement
(in U.S. dollars, in thousands, except per share amount)
Revenue
Research & development
Manufacturing commercialization
Management and administration
Fair value remeasurement of contingent consideration
Other operating income and expenses
Finance costs
Loss before income tax
Income tax (expense)/benefit
Loss attributable to the owners of Mesoblast Limited
Losses per share from continuing operations attributable
to the ordinary equity holders of the Group:
Basic - losses per share
Diluted - losses per share
Note
3
3
3
3
3
4
2021
Year Ended June 30,
2020
2019
7,456
(53,012)
(32,719)
(30,867)
18,687
1,539
(10,714)
(99,630)
819
(98,811)
32,156
(56,188)
(25,309)
(25,609)
1,380
324
(14,109)
(87,355)
9,415
(77,940)
16,722
(59,815)
(15,358)
(21,625)
(6,264)
(334)
(12,080)
(98,754)
8,955
(89,799)
Cents
Cents
Cents
(16.33)
(16.33)
(14.74)
(14.74)
(18.16)
(18.16)
The above consolidated income statement should be read in conjunction with the accompanying Notes.
141
Mesoblast Limited
Consolidated Statement of Comprehensive Income
(in U.S. dollars, in thousands)
Loss for the period
Other comprehensive (loss)/income
Items that may be reclassified to profit and loss
Exchange differences on translation of foreign operations
Items that will not be reclassified to profit and loss
Financial assets at fair value through other comprehensive income
Other comprehensive (loss)/income for the period,
net of tax
Total comprehensive losses attributable to the
owners of Mesoblast Limited
Note
7(b)
7(b)
Year Ended June 30,
2021
(98,811)
2020
(77,940)
2019
(89,799)
(1,524)
1,146
(137)
209
(446)
(4)
(1,315)
700
(141)
(100,126)
(77,240)
(89,940)
The above consolidated statement of comprehensive income should be read in conjunction with the accompanying Notes.
142
Mesoblast Limited
Consolidated Statement of Changes in Equity
(in U.S. dollars, in thousands)
Note Issued Capital
Share Option
Reserve
Investment
Revaluation
Reserve
Foreign
Currency
Translation
Reserve
Retained
Earnings/
(accumulated
losses)
Warrant
Reserve
Total
Balance as of July 1, 2018
Loss for the period
Other comprehensive income/(loss)
Total comprehensive profit/(loss) for the
period
Transactions with owners in their
capacity as owners:
Contributions of equity net of transaction costs
Transfer of services rendered in shares
Transfer of exercised options
Fair value of share-based payments
Reclassification of modified options to liability
17
Balance as of June 30, 2019
7(a)
Balance as of July 1, 2019
Adjustment on adoption of IFRS 16 (net of tax)
Adjusted balance as of July 1, 2019
Loss for the period
Other comprehensive income/(loss)
Total comprehensive profit/(loss) for the
period
Transactions with owners in their
capacity as owners:
Contributions of equity net of transaction costs
Tax credited / (debited) to equity
Transfer of exercised options
Fair value of share-based payments
Balance as of June 30, 2020
Balance as of July 1, 2020
Loss for the period
Other comprehensive income/(loss)
Total comprehensive profit/(loss) for the
period
Transactions with owners in their
capacity as owners:
Contributions of equity net of transaction costs
Tax credited / (debited) to equity
Transfer of exercised options
Fair value of share-based payments
Issuance of warrants
Balance as of June 30, 2021
889,481
—
—
75,974
—
—
21
—
(4)
(39,276) —
— —
(137) —
(380,192) 546,008
(89,799) (89,799)
(141)
—
—
—
(4)
(137)
—
(89,799)
(89,940)
19,441
19,441
1,170
313
—
—
1,483
910,405
910,405
—
910,405
—
—
—
—
(1,170)
(313)
5,533
10
4,060
80,034
80,034
—
80,034
—
—
—
—
—
—
—
—
—
17
— —
— —
— —
— —
— —
— —
— —
(39,413) —
— 19,441
— 19,441
—
—
—
—
—
5,533
—
10
5,543
—
(469,991) 481,052
17
—
17
—
(446)
(39,413) —
— —
(39,413) —
— —
1,146 —
(827)
(469,991) 481,052
(827)
(470,818) 480,225
(77,940) (77,940)
700
—
—
—
(446)
1,146
—
(77,940)
(77,240)
137,840
137,840
—
3,205
—
3,205
7(a) 1,051,450
17
—
—
979
(3,205)
7,522
5,296
85,330
—
—
—
—
—
—
(429)
— —
— —
— —
— —
— —
— —
(38,267) —
— 137,840
— 137,840
—
979
—
—
—
7,522
8,501
—
(548,758) 549,326
1,051,450
—
—
85,330
—
—
(429)
—
209
(38,267) —
— —
(1,524) —
(548,758) 549,326
(98,811) (98,811)
(1,315)
—
—
—
209
(1,524)
—
(98,811)
(100,126)
106,809
106,809
—
4,894
—
—
4,894
7(a) 1,163,153
17
—
—
(91)
(4,894)
12,510
—
7,525
92,855
—
—
—
—
—
—
—
(220)
— —
— —
— —
— —
— —
— 12,969
— 12,969
(39,791) 12,969
— 106,809
— 106,809
—
(91)
—
—
— 12,510
— 12,969
— 25,388
(647,569) 581,397
The above consolidated statement of changes in equity should be read in conjunction with the accompanying Notes.
143
Mesoblast Limited
Consolidated Balance Sheet
(in U.S. dollars, in thousands)
Assets
Current Assets
Cash & cash equivalents
Trade & other receivables
Prepayments
Total Current Assets
Non-Current Assets
Property, plant and equipment
Right-of-use assets
Financial assets at fair value through other comprehensive income
Other non-current assets
Intangible assets
Total Non-Current Assets
Total Assets
Liabilities
Current Liabilities
Trade and other payables
Provisions
Borrowings
Lease liabilities
Total Current Liabilities
Non-Current Liabilities
Deferred tax liability
Provisions
Borrowings
Lease liabilities
Deferred consideration
Total Non-Current Liabilities
Total Liabilities
Net Assets
Equity
Issued Capital
Reserves
(Accumulated losses)/retained earnings
Total Equity
Note
2021
2020
As of June 30,
5(a)
5(b)
5(b)
6(a)
6(b)
5(c)
5(d)
6(c)
5(e)
6(d)
5(f)
6(b)
6(e)
6(d)
5(f)
6(b)
6(f)
7(a)
7(b)
136,881
4,842
6,504
148,227
3,021
9,119
2,080
1,724
580,546
596,490
744,717
19,598
18,710
53,200
2,765
94,273
—
17,017
41,045
8,485
2,500
69,047
163,320
581,397
129,328
1,574
5,646
136,548
2,293
7,978
1,871
3,311
581,601
597,054
733,602
24,972
29,197
32,455
3,519
90,143
730
27,563
57,023
6,317
2,500
94,133
184,276
549,326
1,163,153
65,813
(647,569)
581,397
1,051,450
46,634
(548,758)
549,326
The above consolidated balance sheet should be read in conjunction with the accompanying Notes.
144
Mesoblast Limited
Consolidated Statement of Cash Flows
(in U.S. dollars, in thousands)
Cash flows from operating activities
Commercialization revenue received
Upfront and milestone payments received
Government grants and tax incentives received
Payments to suppliers and employees (inclusive of goods and
services tax)
Interest received
Interest and other costs of finance paid
Income taxes paid
Net cash (outflows) in operating activities
Cash flows from investing activities
Investment in fixed assets
Payments for contingent consideration
Payments for licenses
Net cash (outflows) in investing activities
Cash flows from financing activities
Proceeds from borrowings
Repayment of borrowings
Payments of transaction costs from borrowings
Proceeds from issue of shares
Proceeds from issue of warrants
Payments for share issue costs
Payments for lease liabilities
Net cash inflows by financing activities
Note
2021
Year Ended June 30,
2020
2019
8(b)
6,121
—
68
(106,920)
17
(5,932)
(35)
(106,681)
(1,647)
—
—
(1,647)
—
—
(13)
106,268
12,969
(1,827)
(2,931)
114,466
6,138
129,328
1,415
136,881
7,676
17,500
1,577
(77,710)
546
(5,947)
(7)
(56,365)
(2,096)
(1,027)
(150)
(3,273)
512
(512)
—
144,946
—
(6,277)
(1,625)
137,044
77,406
50,426
1,496
129,328
4,359
26,409
1,654
(86,294)
726
(4,641)
(3)
(57,790)
(279)
(721)
—
(1,000)
43,572
—
(1,614)
30,258
—
(608)
—
71,608
12,818
37,763
(155)
50,426
Net increase in cash and cash equivalents
Cash and cash equivalents at beginning of period
FX gain/(losses) on the translation of foreign bank accounts
Cash and cash equivalents at end of period
8(a)
The above consolidated statement of cash flows should be read in conjunction with the accompanying Notes.
145
Mesoblast Limited
Notes to Consolidated Financial Statements
Mesoblast Limited (“the Company”) and its subsidiaries (“the Group”) are primarily engaged in the development of
regenerative medicine products. The Group’s primary proprietary regenerative medicine technology platform is based on specialized
cells known as mesenchymal lineage cells. The Company was formed in 2004 as an Australian company and has been listed on the
Australian Securities Exchange (the “ASX”) since 2004. In November 2015, the Company listed in the United States of America
(“U.S.”) on the Nasdaq Global Select Market (“Nasdaq”) and from this date has been dual-listed in Australia and the U.S.
These financial statements and notes are presented in U.S. dollars (“$” or “USD” or “US$”), unless otherwise noted, including
certain amounts that are presented in Australian dollars (“AUD” or “A$”) and Singapore dollars (“SGD” or “S$”).
1. Basis of preparation
The general purpose financial statements of Mesoblast Limited and its subsidiaries have been prepared in accordance with
International Financial Reporting Standards, as issued by the International Accounting Standards Board and Australian equivalent
International Financial Reporting Standards, as issued by the Australian Accounting Standards Board. Mesoblast Limited is a for-
profit entity for the purpose of preparing the financial statements.
The financial statements cover Mesoblast Limited and its subsidiaries. The financial statements were authorized for issue by
the board of directors on August 31, 2021. The directors have the power to amend and reissue the financial statements.
(i)
Going concern
The Group held total cash and cash equivalents of $136.9 million as of June 30, 2021. Over the next twelve months in order to
meet our forecast expenditure, including repayment of the Hercules debt facility, cash inflows will be required. Management and the
directors believe the Group will achieve this given plans to complete either one or more strategic partnerships or restructure existing
loan agreements, and have prepared the financial report on a going concern basis. The dependency on these planned objectives
indicates material uncertainty which may cast significant doubt (or substantial doubt as contemplated by Public Company Accounting
Oversight Board (“PCAOB”) standards) on our ability to continue as a going concern and that the Group may be unable to realize our
assets and discharge our liabilities in the normal course of business.
(ii) Historical cost convention
These financial statements have been prepared under the historical cost convention, as modified by the revaluation of financial
assets at fair value through other comprehensive income, financial assets and liabilities (including derivative instruments) at fair value
through profit or loss, certain classes of property, plant and equipment and investment property.
(iii) New and amended standards adopted by the Group
There were no new or amended standards adopted by the Group in the year ended June 30, 2021. These financial statements
follow the same accounting policies as compared to the June 30, 2020 consolidated financial statements and related notes as filed with
the Australian Securities Exchange and the Securities and Exchange Commission.
(iv) New accounting standards and interpretations not yet adopted by the Group
There were no new accounting standards and interpretations not yet adopted by the Group for the June 30, 2021 reporting period
that are expected to materially impact the Group.
(v) Use of estimates
The preparation of these consolidated financial statements requires the Group to make estimates and judgments that affect the
reported amounts of assets, liabilities, income and expenses and related disclosures. On an ongoing basis, the Group evaluates its
significant accounting policies and estimates. Estimates are based on historical experience and on various market-specific and other
relevant assumptions that the Group believes to be reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities.
146
(vi)
Impact of COVID-19
Estimates are assessed each period and updated to reflect current information, such as the economic considerations related to the
impact that COVID-19 could have on the Group’s significant accounting estimates. COVID-19 has not led to a material deterioration
in the Group’s financial circumstances, nor required the Group to utilize government support.
The Group is facing some challenges from the pandemic. The Group’s current and potential future clinical trials have and may
experience some delays given reduced capacity at hospitals for completing activities and impacts on patient mobility for treatments or
final visits. In addition, requested meetings with FDA are delayed by a minimum of 3 months while the public health crisis is in effect,
due to the increased workload burden on agency staff.
Due to the COVID-19 pandemic, countries in which the Group has operations, including Singapore - where our contract
manufacturer is located, have implemented some level of quarantine “stay at home” orders, and other restrictions in order to contain
spread of the virus. Continued restrictions on the movement of people and products may adversely affect our and our contract
manufacturer’s ability to operate efficiently. In addition, the COVID-19 pandemic could also adversely affect our or our contract
manufacturer’s ability to acquire raw materials or components required in our manufacturing process, including bone marrow. As a
result, the manufacturing and the commercialization of remestemcel-L and other product candidates could be adversely affected.
The Group has also seen substantial delays to lead times for certain raw materials, which is being driven by the pandemic. Such
extension of lead times has the potential to delay the ability to manufacture product in a timely manner and could impact our ability to
meet market demand once approved.
2. Significant changes in the current reporting period
(i)
Significant events
The financial position and performance of the Group was affected by the following events during the year ended June 30, 2021:
•
•
•
In August 2020, the Oncologic Drugs Advisory Committee (“ODAC”) of the FDA voted in favor that available data from
a single-arm Phase 3 trial and evidence from additional studies support the efficacy of remestemcel-L in pediatric patients
with SR-aGVHD. Although the FDA considers the recommendation of the panel, the final decision regarding the approval
of the product is made solely by the FDA, and the recommendations by the panel are non-binding.
In September 2020, the FDA issued a Complete Response Letter to Mesoblast’s BLA for remestemcel-L for the treatment
of pediatric SR-aGVHD. Despite the overwhelming ODAC vote, the FDA recommended that Mesoblast conduct at least
one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of
remestemcel-L for SR-aGVHD.
In November 2020, a Type A meeting was held with the FDA to discuss the review of the BLA for remestemcel-L. The
current FDA review team have not agreed to approval. However, there was consensus with the review team on the
proposed optimization of potency assays and on use of biomarkers to demonstrate the product’s bioactivity in-vivo.
In June 2021, the Group met with the FDA’s Center for Biologics Evaluation and Research (CBER) on potential pathways
to regulatory approval of remestemcel-L (SR-aGVHD) in children. It was recommended that the Group as a next step
discuss with CBER’s review team at the Office of Tissue and Advanced Therapies (OTAT) our approach to address
certain outstanding chemistry, manufacturing and controls (CMC) items, including potency assays, which could support a
resubmission of the current BLA for remestemcel-L with a six-month review period.
In August 2020, the Group amended the terms of the Hercules loan and security agreement to defer principal repayments
to March 2021. In January 2021, the Group amended the terms of the loan agreement to extend the interest-only period of
the loan up to March 2022, subject to achieving certain milestones. In March 2021, the Group met the requirements of the
loan and security agreement to defer the interest only period to July 2021. In May 2021, the Group and Hercules amended
the terms of the loan and security agreement to extend the interest-only period to October 1, 2021. In August 2021, as
disclosed in Note 15, the Group and Hercules amended the terms of the loan and security agreement to extend the interest-
only period to January 1, 2022. Presentation at June 30, 2021 has not been changed as a result of this amendment.
In November 2020, the Group entered into a license and collaboration agreement with Novartis for the development,
manufacture, and commercialization of remestemcel-L, with an initial focus on the treatment of acute respiratory distress
syndrome (ARDS) including that associated with COVID-19. The agreement remains subject to certain closing
conditions, including time to analyze the results from the COVID-19 ARDS trial.
147
•
•
•
In December 2020, the Group announced top-line results from the DREAM-HF Phase 3 randomized controlled trial of its
allogeneic cell therapy rexlemestrocel-L in 537 patients with advanced chronic heart failure. Over a mean 30 months of
follow-up, patients with advanced chronic heart failure who received a single endomyocardial treatment with
rexlemestrocel-L on top of maximal therapies had 60% reduction in incidence of heart attacks or strokes and 60%
reduction in death from cardiac causes when treated at an earlier stage in the progressive disease process. Despite
significant reduction in the pre-specified endpoint of cardiac death, there was no reduction in recurrent non-fatal
decompensated heart failure events, which was the trial’s primary endpoint.
In March 2021, the Group announced completion of a A$138.0 million (US$110.0 million) private placement led by a
strategic US investor group through the placement of 60.1 million new fully-paid ordinary shares at a price of A$2.30.
The investors also received warrants to acquire a further 15 million shares at a price of A$2.88 per share, a 25% premium
to the placement price, which may raise up to a further A$43.2 million, on or before March 15, 2028.
In June 2021, the Group and Grünenthal amended the terms of the development and commercialization agreement. The
Group is eligible to receive payments up to US$112.5 million prior to product launch in the European Union, inclusive of
US$17.5 million already received, if certain clinical and regulatory milestones are satisfied and reimbursement targets are
achieved. Cumulative milestone payments could reach US$1 billion depending on the final outcome of Phase 3 studies
and patient adoption. The Group will also receive tiered double-digit royalties on product sales as per the original
agreement.
148
3. Loss before income tax
(in U.S. dollars, in thousands)
Revenue
Commercialization revenue
Milestone revenue
Interest revenue
Total Revenue
Note
2021
2020
2019
Year Ended June 30,
7,434
—
22
7,456
6,614
25,000
542
32,156
5,003
11,000
719
16,722
(18,569)
(31,590)
(24,565)
(23,944)
(37,927)
(10,912)
(26,804)
(379)
(12,510)
(39,693)
(25,100)
(327)
(7,522)
(32,949)
(19,504)
(339)
(4,368)
(24,211)
(1,016)
(1,691)
(1,557)
(4,264)
(7,757)
(5,386)
(6,950)
(585)
(1,508)
(1,574)
(3,667)
(562)
—
(1,577)
(2,139)
(8,276)
(5,168)
(5,854)
(11,356)
(3,360)
(4,098)
(2,389)
(22,482)
(2,683)
(21,981)
(2,795)
(21,609)
5(g)(iii)
18,687
1,380
(6,264)
18,687
1,380
(6,264)
—
68
1,471
—
1,539
—
78
246
—
324
(74)
—
(208)
(52)
(334)
5,225
(15,939)
(10,714)
607
(14,716)
(14,109)
(376)
(11,704)
(12,080)
Clinical trial and research & development
Manufacturing production & development
Employee benefits
Salaries and employee benefits
Defined contribution superannuation expenses
Equity settled share-based payment transactions(1)
Total Employee benefits
Depreciation and amortization of non-current assets
Plant and equipment depreciation
Right of use asset depreciation
Intellectual property amortization
Total Depreciation and amortization of non-current assets
Other Management & administration expenses
Overheads & administration
Consultancy
Legal, patent and other professional fees
Intellectual property expenses (excluding the amount
amortized above)
Total Other Management & administration expenses
Fair value remeasurement of contingent consideration
Remeasurement of contingent consideration
Total Fair value remeasurement of contingent
consideration
Other operating income and expenses
Research & development tax incentive
Government grant revenue
Foreign exchange gains/(losses)
Foreign withholding tax paid
Total Other operating income and expenses
Finance (costs)/gains
Remeasurement of borrowing arrangements(2)
Interest expense
Total Finance costs
Total loss before income tax
(99,630)
(87,355)
(98,754)
(1)
Share-based payment transactions
149
For the years ended June 30, 2021, 2020 and 2019, share-based payment transactions have been reflected in the Consolidated
Statement of Comprehensive Income functional expense categories as follows:
(in U.S. dollars)
Research and development
Manufacturing and commercialization
Management and administration
Equity settled share-based payment transactions
Legal, patent and other professional fees
Total equity settled share-based payment transactions in
the profit and loss
(2) Change in comparative figures
Year Ended June 30,
2021
2020
2019
7,782,330
547,998
4,179,416
12,509,744
—
3,194,695
434,403
3,892,647
7,521,745
—
2,283,646
329,718
1,755,027
4,368,391
620,000
12,509,744
7,521,745
4,988,391
The Group routinely reviews the financial statements for opportunities to improve the quality of financial reporting. The Group
identified an opportunity to enhance the presentation of the Remeasurement for borrowing arrangements within Finance (costs)/gains
and Remeasurement for borrowing arrangements within Other operating income and expenses. The Group considered that changes in
the carrying value of borrowings is primarily due to changes in our estimated future cash flows and key assumptions about the
settlement of the borrowings and these line items in the Consolidated Income Statement should therefore be reported in aggregate, to
provide more relevant information to the users of the financial statements. This change in presentation has been retrospectively
applied to the years ended June 30, 2020 and 2019.
The impact of the reclassification of the prior period financial statements is summarized below:
Year Ended June 30,
2020
Previously
reported
Currently
reported
Effect of
change
Previously
reported
Year Ended June 30,
2019
Currently
reported
Effect of
change
(779)
1,386
—
607
779
(779)
(752)
376
—
(376)
752
(752)
(in U.S. dollars, in thousands)
Other operating income and
expenses
Finance costs
Revenue recognition
Grünenthal arrangement
In September 2019, the Group entered into a strategic partnership with Grünenthal for the development and commercialization
in Europe and Latin America of the Group’s allogeneic mesenchymal precursor cell (“MPC”) product, MPC-06-ID, receiving
exclusive rights to the Phase 3 allogeneic product candidate for the treatment of low back pain due to degenerative disc disease.
The Group received a non-refundable upfront payment of $15.0 million in October 2019, on signing of the contract with
Grünenthal. The Group received a milestone payment in December 2019 of $2.5 million in relation to meeting a milestone event
as part of the strategic partnership with Grünenthal.
In June 2021, the Group announced its intention to leverage the results from a planned US trial to support potential product
approvals in both the US and EU by including 20% EU patients in order to provide regulatory harmonization, cost efficiencies and
streamlined timelines, without initiating an EU trial. As a result, the strategic partnership with Grünenthal has been amended, and
milestone payments relating to R&D and CMC services and other development services which were linked to the Europe trial have
been removed, instead the Group is eligible to receive payments up to US$112.5 million prior to product launch in the EU, inclusive
of US$17.5 million already received, if certain clinical and regulatory milestones are satisfied and reimbursement targets are achieved.
Cumulative milestone payments could reach US$1 billion depending on the final outcome of Phase 3 studies and patient adoption. The
Group will also receive tiered double-digit royalties on product sales as per the original agreement.
The $2.5 million milestone payment received in December 2019 from Grünenthal was considered constrained and is still
considered deferred consideration as of June 30, 2021. Revenue will be recognized when the performance obligation is satisfied,
which is when the clinical trial has recruited the required amount of European patients. There was no milestone revenue recognized in
relation to this strategic partnership with Grünenthal in the year ended June 30, 2021.
150
See Note 23(e) for further details about the Group’s revenue recognition policies.
4. Income tax benefit/(expense)
(in U.S. dollars, in thousands)
Reconciliation of income tax to prima facie tax payable
Loss from continuing operations before income tax
Tax benefit at the Australian tax rate of 30% (2020: 30%)
Tax effect of amounts which are not deductible/(exempt)
in calculating taxable income:
Share-based payments expense
Research and development tax concessions
Foreign exchange translation gains/(losses)
Contingent consideration
Other sundry items
Current year tax expense/(benefit)
Adjustments for current tax of prior periods(1)
Differences in overseas tax rates
Tax benefit not recognized
Change in tax rate on Deferred tax assets
Change in tax rate on Deferred tax liability
Previously unrecognized tax losses now recouped to reduce
deferred tax expense/(benefit)
Income tax expense/(benefit) attributable to loss before
income tax
2021
Year Ended June 30,
2020
2019
(99,630)
(29,889)
(87,355)
(26,207)
(98,754)
(29,626)
2,836
(894)
313
(5,606)
121
(33,119)
(1)
13,218
19,083
(482)
482
1,367
(876)
129
(414)
97
(25,904)
283
9,397
6,809
(3,412)
3,412
1,221
(1,486)
(15)
1,880
91
(27,935)
(18,412)
24,458
12,934
—
—
—
—
—
(819)
(9,415)
(8,955)
(1)
In the year ended June 30, 2019, the adjustments for current tax of prior periods includes a benefit of $18.2 million relating to a
change in estimate in our current tax provision arising from a tax ruling obtained from Inland Revenue Authority of Singapore
on November 15, 2018. This ruling allows the Group to claim additional deductions in relation to earn-out payments arising
from the acquired MSC assets from Osiris. The Group expects to settle the related tax losses within the tax jurisdiction of
Singapore at a future date. The difference in the Australian tax rate of 30% and the tax rate the Group expects to settle these
deferred tax assets at in Singapore, under the tax incentives granted to the Group by the Singapore Economic Development
Board, resulted in $14.0 million being recorded in differences in overseas tax rates for the year.
(in U.S. dollars, in thousands)
Income tax expense/(benefit)
Current tax
Current tax
Total current tax expense/(benefit)
Deferred tax
(Increase)/decrease in deferred tax assets
(Decrease)/increase in deferred tax liabilities
Total deferred tax expense/(benefit)
Income tax expense/(benefit)
2021
Year Ended June 30,
2020
2019
—
—
—
—
—
—
(1,158)
339
(819)
(819)
(12,687)
3,272
(9,415)
(9,415)
(8,856)
(99)
(8,955)
(8,955)
Deferred tax assets have been brought to account only to the extent that it is foreseeable that they are recoverable against future
tax liabilities.
Deferred tax assets are recognized for unused tax losses to the extent that it is probable that future taxable profit will be
available against which the unused tax losses can be utilized. Deferred tax assets are offset against taxable temporary differences
(deferred tax liabilities) when the deferred tax balances relate to the same tax jurisdiction in accordance with our accounting policy.
151
(in U.S. dollars, in thousands)
Amounts that would be recognized directly in equity if
brought to account
Aggregate current and deferred tax arising in the reporting
period and not recognized in net loss or other
comprehensive income but which would have been
directly applied to equity had it been brought to account:
Current tax recorded in equity (if brought to account)
Deferred tax recorded in equity (if brought to account)
(in U.S. dollars, in thousands)
Amounts recognized directly in equity
Aggregate current and deferred tax arising in the reporting
period and not recognized in net loss or other
comprehensive income but debited/credited to equity
Current tax recorded in equity
Deferred tax recorded in equity
(in U.S. dollars, in thousands)
Deferred tax assets not brought to account
Unused tax losses
Potential tax benefit at local tax rates
Other temporary differences
Potential tax benefit at local tax rates
Other tax credits
Potential tax benefit at local tax rates
2021
Year Ended June 30,
2020
2019
(525)
905
380
(2,293)
1,266
(1,027)
(390)
879
489
2021
Year Ended June 30,
2020
2019
—
91
91
—
(979)
(979)
—
—
—
As of June 30,
2021
2020
2019
77,738
55,573
51,807
7,424
6,782
3,130
3,220
88,382
3,220
65,575
3,220
58,157
The Group has not brought to account $424.9 million (2020: $160.5 million, 2019: $151.0 million) of gross tax losses, which
includes the benefit arising from tax losses in overseas countries. As of June 30, 2021 $424.9 million of tax losses not brought to
account have an indefinite life. Gross tax losses of $44.4 million recognized as deferred tax asset expire within a range of 11 to 17
years. The benefits of unused tax losses will only be brought to account when it is probable that they will be realized.
This benefit of tax losses will only be obtained if:
•
•
•
the Group derives future assessable income of a nature and an amount sufficient to enable the benefit from the deductions
for the losses to be realized;
the Group continues to comply with the conditions for deductibility imposed by tax legislation; and
no changes in tax legislation adversely affect the Group in realizing the benefit from the deductions for the losses.
5. Financial assets and liabilities
This note provides information about the Group's financial instruments, including:
•
•
•
•
an overview of all financial instruments held by the Group;
specific information about each type of financial instrument;
accounting policies; and
information used to determine the fair value of the instruments, including judgments and estimation uncertainty involved.
152
The Group holds the following financial instruments:
Financial assets
(in U.S. dollars, in thousands)
As of June 30, 2021
Cash & cash equivalents
Trade & other receivables
Financial assets at fair value through other comprehensive
income
Other non-current assets
As of June 30, 2020
Cash & cash equivalents
Trade & other receivables
Financial assets at fair value through other comprehensive
income
Other non-current assets
(1)
(2)
Fair value through other comprehensive income
Fair value through profit or loss
Financial liabilities
(in U.S. dollars, in thousands)
As of June 30, 2021
Trade and other payables
Borrowings
Contingent consideration
As of June 30, 2020
Trade and other payables
Borrowings
Contingent consideration
Notes
5(a)
5(b)
5(c)
5(d)
5(a)
5(b)
5(c)
5(d)
Notes
5(e)
5(f)
5(g)(iii)
5(e)
5(f)
5(g)(iii)
Assets at
FVOCI(1)
Assets at
FVTPL(2)
Assets at
amortized
cost
—
—
2,080
—
2,080
—
—
1,871
—
1,871
—
—
—
—
—
—
—
—
—
—
136,881
4,842
—
1,724
143,447
129,328
1,574
—
3,311
134,213
Total
136,881
4,842
2,080
1,724
145,527
129,328
1,574
1,871
3,311
136,084
Liabilities at
FVOCI(1)
Liabilities at
FVTPL(2)
Liabilities at
amortized cost
Total
—
—
—
—
—
—
—
—
—
—
25,409
25,409
—
—
45,166
45,166
19,598
94,245
—
113,843
24,972
89,478
—
114,450
19,598
94,245
25,409
139,252
24,972
89,478
45,166
159,616
(1)
(2)
Fair value through other comprehensive income
Fair value through profit or loss
The Group’s exposure to various risks associated with the financial instruments is discussed in Note 10. The maximum exposure
to credit risk at the end of the reporting period is the carrying amount of each class of financial assets mentioned above.
a.
Cash and cash equivalents
(in U.S. dollars, in thousands)
Cash at bank
Deposits at call(1)
As of June 30,
2021
2020
136,430
451
136,881
128,916
412
129,328
(1) As of June 30, 2021 and June 30, 2020, interest-bearing deposits at call include amounts of $0.5 million and $0.4 million,
respectively, held as security and restricted for use.
153
(i) Classification as cash equivalents
Term deposits are presented as cash equivalents if they have a maturity of three months or less from the date of acquisition.
b.
Trade and other receivables and prepayments
(i) Trade receivables
(in U.S. dollars, in thousands)
Trade debtors
Foreign withholding tax recoverable
U.S. Tax credits
Security deposit
Other recoverable taxes (Goods and services tax and
value-added tax)
Trade and other receivables
(in U.S. dollars, in thousands)
Clinical trial research and development expenditure
Prepaid insurance and subscriptions
Other
Prepayments
(ii) Prepayments
As of June 30,
2021
2020
2,000
471
1,473
252
646
4,842
678
471
—
252
173
1,574
As of June 30,
2021
2020
2,823
1,921
1,760
6,504
3,304
1,337
1,005
5,646
(iii) Classification as trade and other receivables
Trade receivables and other receivables represent the principal amounts due at balance date less, where applicable, any
provision for expected credit losses. The Group uses the simplified approach to measuring expected credit losses, which uses a
lifetime expected credit loss allowance. Debts which are known to be uncollectible are written off in the consolidated income
statement. All trade receivables and other receivables are recognized at the value of the amounts receivable, as they are due for
settlement within 60 days and therefore do not require remeasurement.
(iv) Other receivables
These amounts generally arise from transactions outside the usual operating activities of the Group.
(v) Fair values of trade and other receivables
Due to the short-term nature of the current receivables, their carrying amount is assumed to be the same as their fair value.
(vi) Impairment and risk exposure
Information about the impairment of trade and other receivables, their credit quality and the Group’s exposure to credit risk,
foreign currency risk and interest rate risk can be found in Note 10(a) and (b).
c.
Financial assets at fair value through other comprehensive income
Financial assets at fair value through other comprehensive income include the following classes of financial assets:
(in U.S. dollars, in thousands)
Unlisted securities:
Equity securities
As of June 30,
2021
2020
2,080
2,080
1,871
1,871
154
(i) Classification of financial assets at fair value through other comprehensive income
Financial assets at fair value through other comprehensive income comprises equity securities which are not held for trading,
and which the Group has irrevocably elected at initial recognition to recognize in this category. These are strategic investments and
the Group considers this classification to be more relevant.
The financial assets are presented as non-current assets unless they mature, or management intends to dispose of them within
12 months of the end of the reporting period.
(ii) Impairment indicators for financial assets at fair value through other comprehensive income
Impairment losses (and reversal of impairment losses) on equity investments measured at FVOCI are not reported separately
from other changes in fair value. See Note 23(m)(iv) for further details about the Group’s impairment policies for financial assets.
(iii) Amounts recognized in other comprehensive income
For the years ended June 30, 2021, 2020 and 2019, the Group recognized in statement of comprehensive income a gain of $0.2
million, a loss of $0.4 million and a loss of $0.4 thousand respectively, for change in fair value of the financial assets through other
comprehensive income.
(iv) Fair value, impairment and risk exposure
Information about the methods and assumptions used in determining fair value is provided in Note 5(g). None of the financial
assets through other comprehensive income are either past due or impaired.
All financial assets at fair value through other comprehensive income are denominated in USD.
d.
Other non-current assets
(in U.S. dollars, in thousands)
Bank Guarantee
Letter of Credit
U.S. Tax credits
As of June 30,
2021
2020
546
1,178
—
1,724
660
1,178
1,473
3,311
(i) Classification of financial assets as other non-current assets
Bank guarantee
These funds are held in an account named Mesoblast Limited at National Australia Bank according to the terms of a Bank
Guarantee which is security for the sublease agreement for our occupancy of Level 38, 55 Collins Street, Melbourne, Victoria,
Australia. The Bank Guarantee is security for the full and faithful performance and observance by the subtenant of the terms,
covenants and conditions of the sublease. The Bank Guarantee continues in force until it is released by the lessor.
Letter of credit
These funds held in an account named Mesoblast, Inc. at the Bank of America according to the terms of an irrevocable standby
letter of credit which is security for the sublease agreement for our occupancy of 505 Fifth Avenue, New York, New York, United
States of America. The letter of credit is security for the full and faithful performance and observance by the subtenant of the terms,
covenants and conditions of the sublease. The letter of credit is deemed to automatically extend without amendment for a period of
one year at each anniversary.
U.S. Tax credits
The Group filed a return during the year ended June 30, 2021, to claim a refund from the Internal Revenue Service (“IRS”) of
the tax credit arising from prior years Alternative Minimum Tax. This was a result of the changes in the U.S. corporate income tax
155
legislation with the Tax Act. The refund is expected to be received within one year and has therefore been recorded in trade and other
receivables for the year ended June 30, 2021.
(ii) Impairment and risk exposure
No other non-current assets are either past due or impaired.
e.
Trade and other payables
(in U.S. dollars, in thousands)
Trade payables and other payables
Trade and other payables
As of June 30,
2021
2020
19,598
19,598
24,972
24,972
The carrying amounts of trade and other payables are assumed to be the same as their fair values, due to their short-term nature.
f.
Borrowings
(in U.S. dollars, in thousands)
Borrowings
Secured liabilities:
Borrowing arrangements
Less: transaction costs
Amortization of carrying amount, net of payments made
(in U.S. dollars, in thousands)
Borrowings
Current
Non-current
(i) Borrowing arrangements
Hercules
As of June 30,
2021
2020
80,000
(6,751)
20,996
94,245
80,000
(6,738)
16,216
89,478
As of June 30,
2021
2020
53,200
41,045
94,245
32,455
57,023
89,478
In March 2018, the Group entered into a loan and security agreement with Hercules, for a $75.0 million non-dilutive, four-year
credit facility. The Group drew the first tranche of $35.0 million on closing and a further tranche of $15.0 million was drawn in
January 2019. The loan matures in March 2022.
In May 2021, the Group and Hercules amended the terms of the loan and security agreement to extend the interest-only period
to October 1, 2021. In August 2021, as disclosed in Note 15, the Group and Hercules amended the terms of the loan and security
agreement to extend the interest-only period to January 1, 2022. Principal repayments can be further deferred to March 2022, subject
to achieving certain milestones.
Interest on the loan is payable monthly in arrears on the 1st day of the month. At closing date, the interest rate was 9.45%. At
June 30, 2019, in line with increases in the U.S prime rate, the interest rate was 10.45%. On August 1, September 19 and October 31,
2019, in line with the decreases in the U.S. prime rate, the interest rate on the loan decreased to 10.20%, 9.95% and 9.70%,
respectively, and remains at 9.70% at June 30, 2021, in line with the terms of the loan agreement. As at June 30, 2021, the Group
recognized $2.2 million in interest payable within twelve months as a current liability.
In the years ended June 30, 2021 and 2020, the Group recognized gains of $0.4 million and $1.3 million, respectively, in the
Income Statement as remeasurement of borrowing arrangements within finance costs. These remeasurement gains relate to the
adjustment of the carrying amount of our financial liability to reflect the revised estimated future cash flows from our existing credit
facility due to amendments to the agreement which have occurred during the year ended June 30, 2021. The Group have pledged
substantially all of our assets as collateral under the loan facility with Hercules.
156
NovaQuest
On June 29, 2018, the Group drew the first tranche of $30.0 million of the principal amount from the $40.0 million loan and
security agreement with NovaQuest. There is a four-year interest only period, until July 2022, with the principal repayable in equal
quarterly instalments over the remaining period of the loan. The loan matures in July 2026. Interest on the loan will accrue at a fixed
rate of 15% per annum.
All interest and principal payments will be deferred until after the first commercial sale of remestemcel-L for the treatment in
pediatric patients with SR-aGVHD. The Group can elect to prepay all outstanding amounts owing at any time prior to maturity,
subject to a prepayment charge, and may decide to do so if net sales of remestemcel-L for pediatric SR-aGVHD are significantly
higher than current forecasts.
If there are no net sales of remestemcel-L for pediatric SR-aGVHD, the loan is only repayable on maturity in 2026. If in any
annual period 25% of net sales of remestemcel-L for pediatric SR-aGVHD exceed the amount of accrued interest owing and, from
2022, principal and accrued interest owing (“the payment cap”), Mesoblast will pay the payment cap and an additional portion of
excess sales which may be used for early prepayment of the loan. If in any annual period 25% of net sales of remestemcel-L for
pediatric SR-aGVHD is less than the payment cap, then the payment is limited to 25% of net sales of remestemcel-L for pediatric SR-
aGVHD. Any unpaid interest will be added to the principal amounts owing and shall accrue further interest. At maturity date, any
unpaid loan balances are repaid.
Because of this relationship of net sales and repayments, changes in our estimated net sales may trigger an adjustment of the
carrying amount of the financial liability to reflect the revised estimated cash flows. The carrying amount adjustment is recalculated
by computing the present value of the revised estimated future cash flows at the financial instrument’s original effective interest rate.
The adjustment is recognized in the Income Statement as remeasurement of borrowing arrangements within finance costs in the period
the revision is made.
In the year ended June 30, 2021, the Group recognized a gain of $4.8 million in the Income Statement as remeasurement of
borrowing arrangements within finance costs in relation to the adjustment of the carrying amount of our financial liability to reflect the
revised estimated future cash flows as a net result of changes to the key assumptions in development timelines. In the year ended June
30, 2020 the Group recognized a loss of $0.7 million in the Income Statement as remeasurement of borrowing arrangements within
finance costs in relation to the adjustment of the carrying amount of our financial liability to reflect the revised estimated future cash
flows.
As at June 30, 2021, the Group has recognized a current liability of $0.3 million which represents the present value of $0.4
million loan administration fee which is payable annually in June.
The carrying amount of the loan and security agreement with NovaQuest is subordinated to the Group’s floating rate loan with
the senior creditor, Hercules. The Group have pledged a portion of our assets relating to the SR-aGVHD product candidate as
collateral under the loan facility with NovaQuest.
(ii) Compliance with loan covenants
Our loan facilities with Hercules and NovaQuest contain a number of covenants that impose operating restrictions on us, which
may restrict our ability to respond to changes in our business or take specified actions. The Group has an operating objective to at all
times maintain unrestricted cash reserves in excess of six months liquidity. The objective aligns with our loan and security agreement
with Hercules where the Group are obliged to maintain certain levels of cash in the United States, and a minimum unrestricted cash
balance equal to the lesser of: four months liquidity (defined as the prior four calendar months net cash outflows in operating activities
and investing activities, excluding amounts for extraordinary, non-recurring, not regularly scheduled or onetime proceeds and
amounts) plus any balance of accounts payable not paid after the 120th day following the invoice date for such accounts payable; and
the outstanding loan balance.
The Group has complied with the financial and other restrictive covenants of its borrowing facilities during the year ended June
30, 2021 and during the year ended June 30, 2020.
157
(iii) Net debt reconciliation
(in U.S. dollars, in thousands)
As of June 30,
Cash and cash equivalents
Borrowings
Lease liabilities
Net Debt(1)
Cash and cash equivalents
Gross debt - fixed interest rates
Gross debt - variable interest rates
Net Debt(1)
2021
136,881
(94,245)
(11,250)
31,386
136,881
(52,631)
(52,864)
31,386
2020
129,328
(89,478)
(9,836)
30,014
129,328
(49,414)
(49,900)
30,014
(1) Net debt amount includes leases and borrowing arrangements
(in U.S. dollars, in thousands)
Net Debt as at June 30, 2020
Cash Flows(1)
Remeasurement of borrowing arrangements
Other Changes(2)
Acquisition – leases
Foreign exchange adjustments
Net Debt as at June 30, 2021
Liabilities from financing activities
Borrowings
Leases
Sub-total
Other assets
Cash and cash
equivalents
(89,478)
—
5,225
(9,992)
—
—
(94,245)
(9,836)
2,931
—
(3,604)
(395)
(346)
(99,314)
2,931
5,225
(13,596)
(395)
(346)
(11,250) (105,495)
129,328
6,138
—
—
—
1,415
136,881
Total
30,014
9,069
5,225
(13,596)
(395)
1,069
31,386
(1) Cash flows include the payments of lease liabilities which are presented as financing cash flows in the statement of cash flows.
(2) Other changes include modification of leases, accrued interest expense and interest payments for borrowings and leases which
are presented as operating cash flows in the statement of cash flows when paid.
(iv) Fair values of borrowing arrangements
The carrying amount of the borrowings at amortized cost in accordance with our accounting policy is a reasonable
approximation of fair value.
g.
Recognized fair value measurements
(i) Fair value hierarchy
The following table presents the Group's financial assets and financial liabilities measured and recognized at fair value as of
June 30, 2021 and June 30, 2020 on a recurring basis, categorized by level according to the significance of the inputs used in making
the measurements:
As of June 30, 2021
(in U.S. dollars, in thousands)
Financial Assets
Financial assets at fair value through other comprehensive
income:
Equity securities - biotech sector
Total Financial Assets
Financial Liabilities
Financial liabilities at fair value through profit or loss:
Contingent consideration
Total Financial Liabilities
Notes
Level 1
Level 2
Level 3
Total
5(c)
—
—
—
—
2,080
2,080
2,080
2,080
—
—
—
—
25,409
25,409
25,409
25,409
5(g)(iii)
158
As of June 30, 2020
(in U.S. dollars, in thousands)
Financial Assets
Financial assets at fair value through other comprehensive
income:
Equity securities - biotech sector
Total Financial Assets
Financial Liabilities
Financial liabilities at fair value through profit or loss:
Contingent consideration
Total Financial Liabilities
Notes
Level 1
Level 2
Level 3
Total
5(c)
5(g)(iii)
—
—
—
—
—
—
—
—
1,871
1,871
1,871
1,871
45,166
45,166
45,166
45,166
There were no transfers between any of the levels for recurring fair value measurements during the period.
The Group’s policy is to recognize transfers into and transfers out of fair value hierarchy levels as at the end of the reporting
period.
Level 1: The fair value of financial instruments traded in active markets (such as publicly traded derivatives, and trading and
financial assets at fair value through other comprehensive income) is based on quoted market prices at the end of the reporting period.
The quoted market price used for financial assets held by the Group is the current bid price. These instruments are included in level 1.
Level 2: The fair value of financial instruments that are not traded in an active market (for example, foreign exchange contracts)
is determined using valuation techniques which maximize the use of observable market data and rely as little as possible on entity-
specific estimates. If all significant inputs required to fair value an instrument are observable, the instrument is included in level 2.
Level 3: If one or more of the significant inputs is not based on observable market data, the instrument is included in level 3.
This is the case for provisions (contingent consideration) and equity securities (unlisted).
(ii) Valuation techniques used.
The Group did not hold any level 1 or 2 financial instruments as at June 30, 2021 or June 30, 2020.
The Group’s level 3 assets consist of an investment in unlisted equity securities in the biotechnology sector. Level 3 assets were
100% of total assets measured at fair value as at June 30, 2021 and June 30, 2020. The Group’s level 3 liabilities consist of a
contingent consideration provision related to the acquisition of Osiris’ MSC business. Level 3 liabilities were 100% of total liabilities
measured at fair value as at June 30, 2021 and June 30, 2020. The Group used discounted cash flow analysis to determine the fair
value measurements of level 3 instruments.
(iii) Fair value measurements using significant unobservable inputs (level 3)
The following table presents the changes in level 3 instruments for the years ended June 30, 2021 and June 30, 2020:
(in U.S. dollars, in thousands)
Opening balance - July 1, 2019
Amount used during the period
Charged/(credited) to consolidated income statement:
Remeasurement(1)
Closing balance - June 30, 2020
Opening balance - July 1, 2020
Amount used during the period
Charged/(credited) to consolidated income statement:
Remeasurement(2)
Closing balance - June 30, 2021
159
Contingent
consideration
provision
47,534
(988)
(1,380)
45,166
45,166
(1,070)
(18,687)
25,409
(1)
(2)
In the year ended June 30, 2020, a gain of $1.3 million was recognized on the remeasurement of contingent consideration
pertaining to the acquisition of assets from Osiris. This gain is a net result of changes to the key assumptions of the contingent
consideration valuation such as developmental timelines, market penetration, product pricing and the increase in valuation as the
time period shortens between the valuation date and the potential settlement dates of contingent consideration.
In the year ended June 30, 2021, a gain of $18.7 million was recognized on the remeasurement of contingent consideration
pertaining to the acquisition of assets from Osiris. This gain was a net result of changing the key assumptions of the contingent
consideration valuation such as probability of success and developmental timelines primarily as a result of receiving the
Complete Response Letter from the FDA on the BLA for remestemcel-L for the treatment of pediatric SR-aGVHD on
September 30, 2020.
160
(iv) Valuation inputs and relationship to fair value
The following table summarizes the quantitative information about the significant unobservable inputs used in level 3 fair value
measurements:
(in U.S. dollars, in thousands,
except percent data)
Description
Contingent consideration
provision
Fair value
as of
June 30,
2021
25,409
Fair value
as of
June 30,
2020
45,166
Valuation
technique
Discounted
cash flows
Unobservable
inputs(1)
Risk adjusted
discount rate
Range of inputs
(weighted average)
Year Ended
June 30,
2021
11%-13%
(12.5%)
Year Ended
June 30,
2020
11%-13%
(12.5%)
Expected unit
sales price
n/a
n/a
Expected
sales
volumes
n/a
n/a
Probability of
success
Various
Various
Relationship of
unobservable inputs to
fair value
Year ended 30 June, 2021: A
change in the discount rate by
0.5% would increase/decrease
the fair value by 0.3%.
Year ended June 30, 2020: A
change in the discount rate by
0.5% would increase/decrease
the fair value by 0.4%.
Year ended 30 June, 2021: A
change in the price assumptions
by 10% would increase/decrease
the fair value by 3%.
Year ended June 30, 2020: A
10% increase/decrease in the
price assumptions adopted
would increase/decrease the fair
value by 3%.
Year ended 30 June, 2021: A
change in the volume
assumptions by 10% would
increase/decrease the fair value
by 3%.
Year ended June 30, 2020: A
10% increase/decrease in sales
volume assumptions adopted
would increase/decrease the fair
value by 3%.
Year ended 30 June, 2021: A
change in the probability of
success assumptions by 10% and
20% would increase/decrease the
fair value by 8.6% and 17.3%,
respectively.
Year ended June 30, 2020: A
10% and 20% increase in the
probability of success
assumptions would increase the
fair value by 9% and 12.9%,
respectively, and a 10% and
20% decrease in the probability
of success assumptions would
decrease the fair value by 9%
and 18%, respectively.
(1)
There were no significant inter-relationships between unobservable inputs that materially affect fair values.
(v) Valuation processes
In connection with the Osiris acquisition, on October 11, 2013 (the “acquisition date”), an independent valuation of the
contingent consideration was carried out by an independent valuer.
161
For the years ended June 30, 2021 and June 30, 2020, the Group has adopted a process to value contingent consideration
internally. This valuation has been completed by the Group’s internal valuation team and reviewed by the Chief Financial Officer (the
"CFO"). The valuation team is responsible for the valuation model. The valuation team also manages a process to continually refine
the key assumptions within the model, drawing on both internal and external sources. This is done with input from the relevant
business units. The key assumptions in the model have been clearly defined and the responsibility for refining those assumptions has
been assigned to the most relevant business units. For each indication the Group determines the probability of success based on the
current development status within each jurisdiction. Cash flows relevant to each jurisdiction are discounted appropriately based on the
probability of success assumed. The remeasurement charged to the consolidated income statement in the year ended June 30, 2021
was a net result of changing the key assumptions of the contingent consideration valuation such as probability of success and
development timelines primarily as a result of receiving the Complete Response Letter from the FDA on the BLA for remestemcel-L
for the treatment of pediatric SR-aGVHD on September 30, 2020. These assumptions have been updated to reflect current
expectations based on the Group’s discussions with the FDA for potential approval of this BLA. When the outcome of the request for
approval is known, this could change the key assumptions and a further remeasurement of contingent consideration, up or down, could
occur.
The fair value of contingent consideration
(in U.S. dollars, in thousands)
Fair value of cash or stock payable, dependent on
achievement of future late-stage clinical or regulatory
targets
Fair value of royalty payments from commercialization
of the intellectual property acquired
As of June 30,
2021
2020
18,328
28,801
7,081
25,409
16,365
45,166
The main level 3 inputs used by the Group are evaluated as follows:
Risk adjusted discount rate: The discount rate used in the valuation has been determined based on required rates of returns of listed
companies in the biotechnology industry (having regards to their stage of development, their size and
number of projects) and the indicative rates of return required by suppliers of venture capital for
investments with similar technical and commercial risks. This assumption is reviewed as part of the
valuation process outlined above.
Expected unit sales prices:
Expected market sale price of the most comparable products currently available in the market place. This
assumption is reviewed as part of the valuation process outlined above.
Expected sales volumes:
Expected sales volumes of the most comparable products currently available in the market place. This
assumption is reviewed as part of the valuation process outlined above.
Probability of success:
Expected cash flows used to measure contingent consideration are risk adjusted for the probability of
successful development of products. This assumption is reviewed as part of the valuation process
outlined above.
162
6. Non-financial assets and liabilities
a.
Property, plant and equipment
(in U.S. dollars, in thousands)
Year Ended June 30, 2020
Opening net book amount
Additions
Exchange differences
Disposals
Depreciation charge
Closing net book value
As of June 30, 2020
Cost
Accumulated depreciation
Net book value
Year Ended June 30, 2021
Opening net book amount
Additions
Exchange differences
Depreciation charge
Closing net book value
As of June 30, 2021
Cost
Accumulated depreciation
Net book value
Plant and
Equipment
Office Furniture
and Equipment
Computer
Hardware
and Software
Total
204
1,393
(2)
—
(259)
1,336
5,598
(4,262)
1,336
1,336
1,427
(75)
(735)
1,953
6,955
(5,002)
1,953
376
458
9
—
(136)
707
1,766
(1,059)
707
707
138
89
(123)
811
2,009
(1,198)
811
246
152
43
(1)
(190)
250
3,182
(2,932)
250
250
156
9
(158)
257
3,505
(3,248)
257
826
2,003
50
(1)
(585)
2,293
10,546
(8,253)
2,293
2,293
1,721
23
(1,016)
3,021
12,469
(9,448)
3,021
(i) Depreciation methods and useful lives
Depreciation is calculated using the straight-line method to allocate their cost or revalued amounts, net of their residual values,
over the estimated useful lives. The estimated useful lives are:
•
•
•
Plant and equipment 3 – 15 years
Office furniture and equipment 3 – 10 years
Computer hardware and software 3 – 4 years
See Note 23(o) for other accounting policies relevant to property, plant and equipment.
163
b.
Leases
(i) Amounts recognized on the balance sheet
Right-of-use assets
(in U.S. dollars, in thousands)
Year Ended June 30, 2020
Opening net book amount
Initial recognition under IFRS 16 adoption
Additions
Reassessment
Exchange differences
Depreciation charge
Closing net book value
As of June 30, 2020
Cost
Accumulated depreciation
Net book value
Year Ended June 30, 2021
Opening net book amount
Additions
Reassessment
Exchange differences
Depreciation charge
Closing net book value
As of June 30, 2021
Cost
Accumulated depreciation
Net book value
Lease liabilities
Buildings
Manufacturing
Total
—
4,897
—
321
51
(1,509)
3,760
5,269
(1,509)
3,760
3,760
395
2,721
232
(1,691)
5,417
8,665
(3,248)
5,417
—
—
3,844
998
—
(624)
4,218
4,842
(624)
4,218
4,218
—
842
—
(1,358)
3,702
5,684
(1,982)
3,702
—
4,897
3,844
1,319
51
(2,133)
7,978
10,111
(2,133)
7,978
7,978
395
3,563
232
(3,049)
9,119
14,349
(5,230)
9,119
Current
Non-current
Lease liabilities included in the statement of financial position
As of June 30,
2021
2020
2,765
8,485
11,250
3,519
6,317
9,836
The lease liability is measured at the present value of the fixed and variable lease payments net of cash lease incentives that are
not paid at the balance date. Lease payments are apportioned between the finance charges and reduction of the lease liability using the
incremental borrowing rate to achieve a constant rate of interest on the remaining balance of the liability. Lease payments for
buildings exclude service fees for cleaning and other costs. The interest expense (included in finance costs) for leases is $0.6 million
for the year ended June 30, 2021 and $0.5 million for the year ended June 30, 2020. In the year ended June 30, 2021 and 2020, total
payments associated with lease liabilities were $3.5 million and $2.4 million, respectively.
Payments associated with short-term leases with a lease term of 12 months or less, contracts that contain lease and non-lease
components that are cancellable within 12 months and leases of low-value assets are recognized on a straight-line basis as an expense
in profit or loss. The expense relating to short term leases was $3.6 million for the year ended June 30, 2021 and $0.6 million for the
year ended June 30, 2020.
164
(ii) Depreciation methods and useful lives of right-of use assets
Depreciation is calculated using the straight-line method to allocate their cost or revalued amounts, net of their residual values,
over the estimated useful lives. Depreciation for leases for the years ended June 30, 2021 and 2020 was $1.7 million and $1.5 million,
respectively.
(iii) Extension and termination options
Extension options and termination options may be included in the right-of-use asset leases across the Group. These are used to
maximize operational flexibility in terms of managing the assets used in the Group’s operations.
In determining the lease term, management considers all facts and circumstances that create an economic incentive to exercise
an extension option, or not exercise a termination option. Extension options and periods after termination options are only included in
the lease term if the lease is reasonably certain to be extended or not terminated.
A right-of-use asset and lease liability has been recognized in relation to the manufacturing service agreement entered into with
Lonza in October 2019 for the supply of commercial product for the potential approval and launch of remestemcel-L for the treatment
of pediatric acute graft versus host disease in the US market. Management has determined that this agreement has a non-cancellable
lease term of 4.5 years, at which time the Group has the option to exercise an extension or terminate the agreement.
As of June 30, 2021, the anticipated future contractual cash flows relating to the lease component of the Lonza agreement are
$5.0 million on an undiscounted basis, as included within lease liabilities in Note 10(c). The anticipated future contractual cash flows
exclude cashflows beyond the initial non-cancellable lease term of 4.5 years as it is not reasonably certain the Group will extend the
agreement.
See Note 1(iii) and Note 23v for other accounting policies relevant to lease accounting.
c.
Intangible assets
(in U.S. dollars, in thousands)
Year Ended June 30, 2020
Opening net book amount
Additions
Exchange differences
Amortization charge
Closing net book amount
As of June 30, 2020
Cost
Accumulated amortization
Accumulated impairment
Net book amount
Year Ended June 30, 2021
Opening net book amount
Additions
Exchange differences
Amortization charge
Closing net book amount
As of June 30, 2021
Cost
Accumulated amortization
Accumulated impairment
Net book amount
Goodwill
Acquired licenses
to patents
In-process
research and
development
acquired
Current marketed
products
Total
134,453
—
—
—
134,453
1,744 427,779
—
50
—
(2)
(119)
—
1,673 427,779
19,150 583,126
50
—
(1)
1
(1,455)
(1,574)
17,696 581,601
134,453
—
—
134,453
2,862 489,698
—
(1,189)
(61,919)
—
1,673 427,779
24,000 651,013
(7,493)
(6,304)
(61,919)
—
17,696 581,601
134,453
—
—
—
134,453
134,453
—
—
134,453
165
1,673 427,779
500
—
1
—
—
(102)
2,072 427,779
17,696 581,601
—
500
21
22
(1,577)
(1,475)
16,242 580,546
3,407 489,698
—
(1,335)
(61,919)
—
2,072 427,779
23,999 651,557
(9,092)
(7,757)
(61,919)
—
16,242 580,546
(i) Carrying value of in-process research and development acquired by product
(in U.S. dollars, in thousands)
Cardiovascular products(1)
Intravenous products for metabolic diseases and
inflammatory/immunologic conditions(2)
MSC products(3)
As of
June 30,
2021
As of
June 30,
2020
254,351 254,351
70,730
70,730
102,698 102,698
427,779 427,779
(1)
(2)
(3)
Includes rexlemestrocel-L (MPC-150-IM) for the treatment or prevention of chronic heart failure and MPC-25-IC for the
treatment or prevention of acute myocardial infarction
Includes MPC-300-IV for the treatment of biologic-refractory rheumatoid arthritis and diabetic nephropathy
Includes remestemcel-L for the treatment of children with SR-aGVHD and remestemcel-L for the treatment of Crohn’s disease
For all products included within the above balances, the underlying currency of each item recorded is USD.
(ii) Amortization methods and useful lives
The Group amortizes intangible assets with a finite useful life using the straight-line method over the following periods:
•
•
Acquired licenses to patents 7 – 16 years
Current marketed products 15 – 20 years
See Note 23(p) for the other accounting policies relevant to intangible assets and Note 23(j) for the Group’s policy regarding
impairments.
(iii) Significant estimate: Impairment of goodwill and assets with an indefinite useful life
The Group tests annually whether goodwill and its assets with indefinite useful lives have suffered any impairment in
accordance with its accounting policy stated in Note 23(j). The recoverable amounts of these assets and cash-generating units have
been determined based on fair value less costs to dispose calculations, which require the use of certain assumptions. A full annual
impairment assessment was performed at March 31, 2021 and no impairment of the in-process research and development and
goodwill was identified.
(iv) Impairment tests for goodwill and intangible assets with and indefinite useful life
The Group has recognized goodwill as a result of two separate acquisitions. Goodwill of $118.4 million was recognized on
acquisition of Angioblast Systems Inc. in 2010, $13.9 million was recognized on the acquisition of the MSC assets from Osiris (“MSC
business combination”) in 2013 and $2.1 million was recognized on finalization of the MSC business combination of Osiris in 2015.
In all cases the goodwill recognized represented excess in the purchase price over the net identifiable assets and in-process research
and development acquired in the transaction.
On acquisition, goodwill was not able to be allocated to the cash generating unit (“CGU”) level or to a group of CGU given the
synergies of the underlying research and development. For the purpose of impairment testing, goodwill is monitored by management
at the operating segment level. The Group is managed as one operating segment, being the development of cell technology platform
for commercialization.
IFRS requires that acquired in-process research and development be measured at fair value and carried as an indefinite life
intangible asset subject to annual impairment reviews. The Group have recognized in-process research and development as a result of
two separate acquisitions. In-process research and development of $387.0 million was recognized on the acquisition of Angioblast
Systems Inc. in 2010 and $126.7 million was recognized on the acquisition of assets from Osiris in 2013 and $24.0 million was
reclassified to current marketed products upon the TEMCELL asset becoming available for use in Japan. In 2016, the Group fully
impaired $61.9 million of in-process research and development relating to our product candidates, MPC-MICRO-IO for the treatment
of age-related macular degeneration and MPC-CBE for the expansion of hematopoietic stem cells within cord blood, as the Group
166
suspended further patient enrollment of the Phase IIa MPC-MICRO-IO clinical trial and the Phase III MPC-CBE clinical trial as the
Group prioritized the funding of our Tier 1 product candidates. The remaining carrying amount of in-process research and
development as at June 30, 2021 and June 30, 2020 was $427.8 million. The Group still believe these product candidates remain
viable upon further funding, or partnership, and accordingly these products should not be regarded as abandoned, where typically,
abandoned programs would be closed down and the related research and development efforts are considered impaired and the asset is
fully expensed.
In-process research and development acquired is considered to be an indefinite life intangible asset on the basis that it is
incomplete and cannot be used in its current form (see Note 23(p)(iii)). The intangible asset’s life will remain indefinite until such
time it is completed and commercialized or impaired. The carrying value of in-process research and development is a separate asset
which has been subject to impairment testing at the cash generating unit level, which has been determined to be at the product level.
The recoverable amount of both goodwill and in-process research and development was assessed as of March 31, 2021 based on
the fair value less costs to dispose. Management assess for indicators of impairment as at June 30, 2021 including considering events
up to the date of the approval financial statements. No impairment as at June 30, 2021, was identified.
(v) Key assumptions used for fair value less costs to dispose calculations
In determining the fair value less costs to dispose the Group has given consideration to the following internal and external
indicators:
•
•
•
•
discounted expected future cash flows of programs valued by the Group’s internal valuation team and reviewed by the
CFO. The valuation team is responsible for the valuation model. The valuation team also manages a process to continually
refine the key assumptions within the model. This is done with input from the relevant business units. The key
assumptions in the model have been clearly defined and the responsibility for refining those assumptions has been
assigned to the most relevant business units. When determining key assumptions, the business units refer to both external
sources and past experience as appropriate. The valuation is considered to be level 3 in the fair value hierarchy due to
unobservable inputs used in the valuation;
the scientific results and progress of the trials since acquisition;
the market capitalization of the Group on the ASX (ASX:MSB) on the impairment testing date of March 31, 2021; and
the valuation of the Group’s assets from an independent valuation as of March 31, 2020.
Costs of disposal were assumed to be immaterial as at March 31, 2021.
Discounted cash-flows used a real post-tax discount rate range of 13.8% to 15.5%, and include estimated real cash inflows and
outflows for each program through to expected patent expiry which ranges from 12 to 24 years.
In relation to cash outflows consideration has been given to cost of goods sold, selling costs and clinical trial schedules
including estimates of numbers of patients and per patient costs. Associated expenses such as regulatory fees and patent maintenance
have been included as well as any further preclinical development if applicable.
In relation to cash inflows consideration has been given to product pricing, market population and penetration, sales rebates and
discounts, launch timings and probability of success in the relevant applicable markets.
The assessment of goodwill showed the recoverable amount of the Group’s operating segment, including goodwill and
remaining in-process research and development, exceeds the carrying amounts, and therefore there is no impairment. Additionally, the
recoverable amount of remaining in-process research and development also exceeds the carrying amounts, and therefore there is no
impairment.
167
There are no standard growth rates applied, other than our estimates of market penetration which increase initially, plateau and
then decline.
The assessment of the recoverable amount of each product has been made in accordance with the discounted cash-flow
assumptions outlined above. The assessment showed that the recoverable amount of each product exceeds the carrying amount and
therefore there is no impairment.
(vi) Impact of possible changes in key assumptions
The Group has considered and assessed reasonably possible changes in the key assumptions and has not identified any instances
that could cause the carrying amount of our intangible assets as at June 30, 2021 to exceed its recoverable amount.
Whilst there is no impairment, the key sensitivities in the valuation remain the continued successful development of our
technology platform. If the Group is unable to successfully develop our technology platforms, an impairment of the carrying amount
of our intangible assets may result.
d.
Provisions
(in U.S. dollars, in thousands)
Contingent consideration
Employee benefits
Provision for license agreements
As of
June 30, 2021
Non-current
Current
Total
Current
As of
June 30, 2020
Non-current
10,764
4,195
3,751
18,710
14,645
47
2,325
17,017
25,409
4,242
6,076
35,727
19,699
5,748
3,750
29,197
25,467
83
2,013
27,563
Total
45,166
5,831
5,763
56,760
(i) Information about individual provisions and significant estimates
Contingent consideration
The contingent consideration provision relates to the Group’s liability for certain milestones and royalty achievements
pertaining to the acquired MSC assets from Osiris. Further disclosures can be found in Note 5(g)(iii).
Employee benefits
The provision for employee benefits relates to the Group’s liability for annual leave, short term incentives and long service
leave.
Employee benefits include accrued annual leave. As of June 30, 2021 and 2020, the entire amount of the accrual was $1.0
million and $0.8 million respectively, and is presented as current, since the Group does not have an unconditional right to defer
settlement for any of these obligations.
(ii) Movements
The contingent consideration provision relates to the Group’s liability for certain milestones and royalty achievements. Refer to
Note 5(g)(iii) for movements in contingent consideration for the years ended June 30, 2021 and 2020.
168
e.
Deferred tax balances
(i) Deferred tax balances
(in U.S. dollars, in thousands)
Deferred tax assets
The balance comprises temporary differences attributable to:
Tax losses
Other temporary differences
Total deferred tax assets
Deferred tax liabilities
The balance comprises temporary differences attributable to:
Intangible assets
Total deferred tax liabilities
Net deferred tax liabilities
As of June 30,
2021
2020
71,916
8,248
80,164
72,899
6,196
79,095
80,164
80,164
—
79,825
79,825
730
(ii) Movements
(in U.S. dollars, in thousands)
As of June 30, 2019
Charged/(credited) to:
- profit or loss
- directly to equity
As of June 30, 2020
Charged/(credited) to:
- profit or loss
- directly to equity
As of June 30, 2021
(1) Deferred tax assets are netted against deferred tax liabilities.
f.
Deferred consideration
(in U.S. dollars, in thousands)
Opening balance(1)(2)
Milestone consideration received during the period(2)
Amount recognized as revenue during the period(1)
Balance as of the end of the period
Other
temporary
differences(1)
(DTA)
Intangible
assets
(DTL)
(3,687)
76,553
Total (DTL)
11,124
Tax losses(1)
(DTA)
(61,742)
(10,727)
(430)
(72,899)
(1,960)
(549)
(6,196)
3,272
—
79,825
(9,415)
(979)
730
1,449
(466)
(71,916)
(2,609)
557
(8,248)
339
—
80,164
(821)
91
—
As of June 30,
2021
2020
2,500
—
—
2,500
10,000
2,500
(10,000)
2,500
(1)
The $10.0 million opening balance in deferred consideration represents the portion of the $20.0 million upfront technology
access fee received from Tasly that had not been recognized as revenue. In accordance with the Group’s accounting policy,
revenue related to the licensing of intellectual property is only recognized to the extent that control has been transferred to the
customer. In the year ended June 30, 2020, the Group recognized the remaining $10.0 million of the upfront technology access
fee received in revenue as the control for this portion of revenue was transferred to Tasly based on our decision regarding the
exercise of our rights in the terms and conditions of the agreement.
(2)
The $2.5 million milestone payment received in December 2019 from Grünenthal was considered constrained and resulted in
deferred consideration as of June 30, 2021.
169
7. Equity
a.
Contributed equity
(i) Share capital
2021
2020
Shares No.
As of June 30,
2019
2021
2020
(U.S. dollars, in thousands)
2019
Contributed equity
(i) Share capital
648,696,070
Ordinary shares
Less: Treasury Shares
(771,983)
Total Contributed Equity 647,924,087
583,949,612
(3,500,000)
580,449,612
498,626,208
(3,500,000)
495,126,208
1,163,153
—
1,163,153
1,051,450
—
1,051,450
910,405
—
910,405
(ii) Movements in ordinary share capital
Opening balance
Issues of ordinary shares
during the period
Exercise of share options(1)
Transfer to employee share
trust(1)
Share based compensation for
services rendered
Placement of shares under a
share
placement agreement(2)(3)
Transaction costs arising on
share issue
Total contributions of equity
during the period
2021
583,949,612
As of June 30,
2020
Shares No.
498,626,208
2019
2021
As of June 30,
2020
(U.S. dollars, in thousands)
2019
482,639,654 1,051,450
910,405
889,481
—
4,223,404
313,108
9,223
4,364
258
3,450,000
—
—
—
1,187,168
600,000
1,209,187
1,867
864
1,170
60,109,290
80,500,000
14,464,259
97,031
139,483
20,000
—
—
—
(1,312)
(6,871)
(817)
64,746,458
85,323,404
15,986,554
106,809
137,840
20,611
Share options reserve transferred
to
equity on exercise of options
Ending balance
—
648,696,070
—
583,949,612
3,205
498,626,208 1,163,153 1,051,450
4,894
—
313
910,405
(1) Options are issued to employees, directors and consultants in accordance with the Mesoblast Employee Share Option Plan.
From July 1, 2020, unpaid shares are issued to the share trust to enable future option exercises to be settled. On exercise of
options, the proceeds of the exercise are recorded in ordinary share capital in Mesoblast Limited and the exercise is settled by
transfer of the shares from the share trust to the employee. Prior to July 1, 2020, the shares issued and share capital received on
the exercise of options were recorded in ordinary share capital.
(2)
In October 2019, the Group completed a A$75.0 million (US$50.7 million) capital raise through the placement of 37.5 million
new fully-paid ordinary shares at a price of A$2.00 per share to existing and new institutional investors, representing a 3.15%
discount to the 10 day volume weighted average price calculated at the close of trading. In May 2020, the Group completed a
A$138.0 million (US$88.8 million) capital raise through the placement of 43.0 million new fully-paid ordinary shares at a price
of A$3.20 per share to existing and new institutional investors, representing a 7% discount to the 5 day volume weighted
average price calculated at the close of trading May 8, 2020. During the year ended June 30, 2019, a $20.0 million equity
purchase of Mesoblast Limited was completed at A$1.86 per share, representing a 20% premium to a blended volume weighted
average price calculated over three months, one month and one day.
(3)
In March 2021, 60,109,290 shares were issued in an equity purchase of Mesoblast Limited at A$2.30 per share to existing and
new institutional investors, representing a 6.50% discount to the price calculated at the close of trading February 25, 2021. The
investors also received warrants to acquire a further 15 million shares at a price of A$2.88 per share, a 25% premium to the
170
placement price, which may raise up to a further A$43.2 million, on or before March 15, 2028. These warrants have been
classified within warrant reserves, refer to Note 7(c).
(iii) Movements of shares in share trust
Opening balance(1)
Movement of shares in share trust
Transfer to employee share trust(2)
Exercise of share options(2)
Ending balance
As of June 30
2021
2020
Shares No.
3,500,000
3,500,000
As of June 30
2021
2020
(U.S. dollars, in thousands)
—
3,450,000
(6,178,017)
771,983
—
—
3,500,000
—
—
—
—
—
—
—
(1)
In July 2020, the Group formed the Mesoblast Employee Share Trust, being a new trust formed to administer the Group’s
employee share scheme. Prior to forming the new trust, the Group had been using the Mesoblast Limited Employee Share Trust
for administering some aspects of the Group’s employee share scheme. In July 2020, 3,500,000 shares were transferred from
Mesoblast Limited Employee Share Trust to the new Mesoblast Employee Share Trust. These trusts have been consolidated, as
the substance of the relationship is that the trusts are controlled by the Group.
(2) Options are issued to employees, directors and consultants in accordance with the Mesoblast Employee Share Option Plan.
From July 1, 2020, unpaid shares are issued to the share trust to enable future option exercises to be settled. On exercise of
options, the proceeds of the exercise are recorded in ordinary share capital in Mesoblast Limited and the exercise is settled by
transfer of the shares from the share trust to the employee. Prior to July 1, 2020, the shares issued and share capital received on
the exercise of options were recorded in ordinary share capital.
(iv) Ordinary shares
Ordinary shares participate in dividends and the proceeds on winding up of the Group in equal proportion to the number of
shares held. At shareholders meetings each ordinary share is entitled to one vote when a poll is called, otherwise each shareholder has
one vote on a show of hands. Ordinary shares have no par value and the Company does not have a limited amount of authorized
capital.
(v) Employee share options
Information relating to the Group’s employee share option plan, including details of shares issued under the scheme, is set out in
Note 17.
b.
Reserves
(i) Reserves
(in U.S. dollars, in thousands)
Share-based payments reserve
Investment revaluation reserve
Foreign currency translation reserve
Warrants reserve
As at June 30,
2021
2020
92,855
(220)
(39,791)
12,969
65,813
85,330
(429)
(38,267)
—
46,634
171
(ii) Reconciliation of reserves
(in U.S. dollars, in thousands)
Share-based payments reserve
Opening balance
Tax credited / (debited) to equity
Transfer to ordinary shares on exercise of options
Share-based payment expense for the year
Closing Balance
Investment revaluation reserve
Opening balance
Changes in the fair value of financial assets through other
comprehensive income
Closing Balance
Foreign currency translation reserve
Opening balance
Currency gain/(loss) on translation of foreign operations
net assets
Closing Balance
Warrant reserve
Opening balance
Warrants fair value at issue date - March 18, 2021
Closing Balance
As at June 30,
2021
2020
85,330
(91)
(4,894)
12,510
92,855
80,034
979
(3,205)
7,522
85,330
(429)
209
(220)
17
(446)
(429)
(38,267)
(39,413)
(1,524)
1,146
(39,791)
(38,267)
—
12,969
12,969
—
—
—
(iii) Nature and purpose of reserves
Share-based payment reserve
The share-based payments reserve is used to recognize:
•
•
the fair value(1) of options issued but not exercised; and
the fair value(1) of deferred shares granted but not yet vested.
(1)
The fair value recognized is determined at the acceptance date, which is the date at which the entity and the employee agree to a
share-based payment arrangement, being when the entity and the employee have a shared understanding of the terms and
conditions of the arrangement.
Foreign currency translation reserve
Exchange differences arising on translation of a foreign controlled entity are recognized in other comprehensive income and
accumulated in a separate reserve within equity. The cumulative amount is reclassified to profit or loss when the net investment is
disposed of.
Warrants reserve
In March 2021, the Group completed a A$138.0 million (US$110.0 million) private placement of 60,109,290 new fully-paid
ordinary shares at a price of A$2.30. As part of this placement, the Group also issued one warrant for every four ordinary shares issued
in the placement, which resulted in a further 15,027,327 warrants issued. Each warrant has an exercise price of A$2.88 per share and a
7 year term. The Group has a right to compel exercise of the warrants at any time, subject to the price of the Group’s ordinary shares
trading at least A$4.32 for 45 consecutive days on the ASX. The warrants do not confer any rights to dividends or a right to participate
in a new issue without exercising the warrant.
The terms of the warrants include certain anti-dilution clauses, which adjust the exercise price or conversion ratio in the event of
a rights issue or bonus issue. Management analyzed these clauses and determined the fixed-for-fixed requirement was still satisfied
because the relative rights of shareholders and warrant holders were maintained. Therefore the warrants were classified as equity. The
172
warrants were initially measured in equity at fair value, which was determined using a Monte Carlo simulation (refer to Note 7(b)(iv)),
with the residual consideration being attributed to the ordinary shares issued in the same transaction. The warrants are not remeasured
for subsequent changes in fair value.
(iv) Fair value of warrants
The warrants granted are not traded in an active market and therefore the fair value has been estimated by using the Monte Carlo
pricing model based on the following assumptions. Key terms of the warrants are included above. The following assumptions were
based on observable market conditions that existed at the issue date.
Assumption
Share Price
Exercise Price
Expected Term
Dividend Yield
Expected Volatility
A$-US$ FX Spot Rate
Risk Free Interest Rate
Fair value per warrant
Fair value
8. Cash flow information
At Issue date -
March
18, 2021
A$2.41
A$2.88
7 years
0%
66.88%
0.7827
1.24%
A$1.103
US$0.863
12,968,583
$
Rationale
Closing share price on valuation date from external market source
As per subscription agreement
As per subscription agreement
Based on Company’s nil dividend history
Based on historical volatility data for the Company
Closing FX rate on valuation date from the Reserve Bank of Australia
historical foreign exchange rate tables
Based on the mid-point of the Australian Government issued 5 year
and 10 year bonds
Determined using Monte Carlo pricing models with the inputs above
Fair value of 15,027,327 warrants as at issue date
(in U.S. dollars, in thousands)
(a) Reconciliation of cash and cash equivalents
Cash at bank
Deposits at call
(in U.S. dollars, in thousands)
(b) Reconciliation of net cash flows used in operations
with loss after income tax
Loss for the period
Add/(deduct) net loss for non-cash items as follows:
Depreciation and amortization
Foreign exchange (gains)/losses
Finance costs
Remeasurement of borrowing arrangements
Remeasurement of contingent consideration
Payment for services rendered in shares
Equity settled share-based payment
Deferred tax benefit
Change in operating assets and liabilities:
Decrease/(increase) in trade and other receivables
Decrease/(increase) in prepayments
Decrease/(increase) in tax assets
Increase/(decrease) in trade creditors and accruals
Increase/(decrease) in provisions
Increase/(decrease) in deferred consideration
Net cash outflows used in operations
As of June 30,
2020
128,916
412
129,328
2021
136,430
451
136,881
2019
50,005
421
50,426
Year Ended June 30,
2021
(98,811)
2020
(77,940)
2019
(89,799)
4,264
(1,499)
10,004
(5,225)
(18,687)
—
12,510
(819)
3,667
(302)
8,800
(607)
(1,380)
—
7,522
(9,415)
2,139
(154)
6,914
376
6,264
620
4,368
(8,955)
(1,739)
(213)
—
(5,061)
(1,405)
—
(106,681)
890
2,292
1,499
12,508
3,601
(7,500)
(56,365)
4,974
5,237
1,729
(3,972)
2,469
10,000
(57,790)
173
9. Significant estimates, judgments and errors
The preparation of financial statements requires the use of accounting estimates which, by definition, will seldom equal the
actual results. Management also needs to exercise judgment in applying the Group’s accounting policies.
This note provides an overview of the areas that involved a higher degree of judgment or complexity, and of items which are
more likely to be materially adjusted due to estimates and assumptions turning out to be wrong. Detailed information about each of
these estimates and judgments is included in Notes 1 to 8 together with information about the basis of calculation for each affected
line item in the financial statements. In addition, this note also explains where there have been actual adjustments this year as a result
of an error and of changes to previous estimates.
Significant estimates and judgments
The areas involving significant estimates or judgments are:
•
•
•
•
•
•
•
•
•
recognition of revenue (Note 3 and Note 23(e));
fair value of contingent liabilities and contingent purchase consideration in a business combination (Note 5(g) and 13);
recoverable amount of goodwill and other intangible assets including in-process research and development (Note 6(c));
useful life of intangible assets (Note 6(c));
recognition of deferred tax assets and deferred tax liabilities (Note 4);
accrued research and development and manufacturing commercialization expenses (Note 5(e));
fair value of share-based payments (Note 17);
fair value of borrowings (Note 5(f)); and
recognition of pre-launch inventory costs (Note 23(f)).
The preparation of these consolidated financial statements requires the Group to make estimates and judgments that affect the
reported amounts of assets, liabilities, income and expenses and related disclosures. On an ongoing basis, the Group evaluates its
significant accounting policies and estimates. Estimates are based on historical experience and on various market-specific and other
relevant assumptions that the Group believes to be reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities.
10. Financial risk management
This note explains the Group’s exposure to financial risks and how these risks could affect the Group’s future financial
performance. Current year profit and loss information has been included where relevant to add further context.
Risk
Market risk – currency risk
Exposure arising from
Future commercial transactions
Recognized financial assets and
liabilities not denominated in the
functional currency of each entity
within the Group
Measurement
Cash flow forecasting
Sensitivity analysis
Market risk – interest rate
risk
Long-term borrowings at floating
rates
Sensitivity analysis
Term deposits at fixed rates
Sensitivity analysis
174
Management
The future cash flows of each
currency are forecast and the
quantum of cash reserves held
for each currency are managed in
line with future forecasted
requirements. Cross currency
swaps are undertaken as
required.
The facility can be refinanced
and/or repaid. Interest rate swaps
can be entered into to convert the
floating interest rate to a fixed
interest rate as required.
Vary length of term deposits,
utilize interest bearing accounts
and periodically review interest
rates available to ensure we earn
interest at market rates.
Market risk – price risk
Long-term borrowings
Sensitivity analysis
Credit risk
Cash and cash equivalents, and
trade and other receivables
Aging analysis
Credit ratings
Liquidity risk
Cash and cash equivalents
Borrowings
Rolling cash flow forecasts
Forecasts of net sales of the
product underlying the
NovaQuest borrowing
arrangement are updated on a
quarterly basis to evaluate the
impact on the carrying amount of
the financial liability.
Only transact with the best risk
rated banks available in each
region giving consideration to
the products required.
Future cash flows requirements
are forecasted and capital raising
strategies are planned to ensure
sufficient cash balances are
maintained to meet the Group’s
future commitments.
a. Market risk
(i) Currency risk
The Group has foreign currency amounts owing relating to clinical, regulatory and overhead activities and foreign currency
deposits held primarily in the Group’s Australian based entity, whose functional currency is the A$. The Group also has foreign
currency amounts owing in the Group’s Swiss and Singapore based entities, whose functional currencies are the US$. The Group also
has foreign currency amounts owing in various other non-US$ currencies in A$ and US$ functional currency entities in the Group
relating to clinical, regulatory and overhead activities. These foreign currency balances give rise to a currency risk, which is the risk of
the exchange rate moving, in either direction, and the impact it may have on the Group’s financial performance.
Currency risk is minimized by ensuring the proportion of cash reserves held in each currency matches the expected rate of spend
of each currency.
As of June 30, 2021, the Group held 89% of its cash in USD, and 11% in AUD. As of June 30, 2020 the Group held 86% of its
cash in USD, and 14% in AUD.
175
The balances held at the end of the year that give rise to currency risk exposure are presented in USD in the following table,
together with a sensitivity analysis which assesses the impact that a change of +/-20% in the exchange rate as of June 30, 2021 and
June 30, 2020 would have had on the Group’s reported net profits/(losses) and/or equity balance.
(in U.S. dollars, in thousands)
As of June 30, 2021
Bank accounts - USD
Bank accounts - CHF
Bank accounts - SGD
Bank accounts - EUR
Trade and other receivables - SGD
Trade and other receivables - CHF
Trade and other receivables - EUR
Trade payables and accruals - USD
Trade payables and accruals - AUD
Trade payables and accruals - SGD
Trade payables and accruals - GBP
Trade payables and accruals - EUR
Trade payables and accruals - CHF
Provisions - USD
Provisions - SGD
(in U.S. dollars, in thousands)
As of June 30, 2020
Bank accounts - USD
Bank accounts - CHF
Bank accounts - SGD
Bank accounts - EUR
Trade and other receivables - SGD
Trade and other receivables - CHF
Trade and other receivables - EUR
Trade payables and accruals - USD
Trade payables and accruals - AUD
Trade payables and accruals - SGD
Trade payables and accruals - GBP
Trade payables and accruals - EUR
Trade payables and accruals - CHF
Provisions - USD
Provisions - SGD
Foreign
currency
balance held
+20%
-20%
Profit/(Loss)
USD
Profit/(Loss)
USD
USD 2 $
CHF 68 $
SGD 33 $
EUR 147 $
SGD 369 $
CHF 5 $
EUR 136 $
(USD 1,792) $
(AUD 392) $
(SGD 356) $
(GBP 47) $
EUR (53) $
(CHF 53) $
(USD 1,750) $
(SGD 94) $
$
0 $
15 $
5 $
35 $
55 $
1 $
32 $
(358) $
(59) $
(53) $
(13) $
(13) $
(12) $
(350) $
(14) $
(729) $
(0)
(15)
(5)
(35)
(55)
(1)
(32)
358
59
53
13
13
12
350
14
729
Foreign
currency
balance held
+20%
-20%
Profit/(Loss)
USD
Profit/(Loss)
USD
USD 402 $
CHF 87 $
SGD 112 $
EUR 46 $
SGD 141 $
CHF 2 $
EUR 43 $
(USD 4,872) $
(AUD 731) $
(SGD 124) $
(GBP 60) $
(EUR 124) $
(CHF 37) $
(USD 0) $
(SGD 98) $
$
80 $
18 $
16 $
10 $
20 $
0 $
10 $
(974) $
(100) $
(18) $
(15) $
(28) $
(8) $
(350) $
(14) $
(1,353) $
(80)
(18)
(16)
(10)
(20)
(0)
(10)
974
100
18
15
28
8
350
14
1,353
(ii) Cash flow and fair value interest rate risk
The Group’s main interest rate risk arises from long-term borrowings with a floating interest rate, which exposes the Group to
cash flow interest rate risk. As interest rates fluctuate, the amount of interest payable on financing where the interest rate is not fixed
will also fluctuate. This interest rate risk can be managed by interest rate swaps which can be entered into to convert the floating
interest rate to a fixed interest rate as required. Additionally, the Group can repay its loan facility at its discretion and can also
refinance if the terms are suitable in the marketplace or from the existing lender.
The Group did not enter into any interest rate swaps during the year ended June 30, 2021.
176
The exposure of the Group’s borrowing to interest rate changes are as follows:
(in U.S. dollars, in thousands, except percent data)
Financial liabilities
Current borrowings
Variable rate borrowings - Hercules
Non-current borrowings
Variable rate borrowings - Hercules
As of
June 30, 2021
Total
% of total
loans
As of
June 30, 2020
Total
% of total loans
52,864
55%
27,949
—
52,864
0%
55%
21,951
49,900
31%
25%
56%
An analysis by maturities is provided in Note 10(c) below. The percentage of total loans shows the proportion of loans that are
currently at variable rates in relation to the total amount of borrowings.
The borrowings which expose the Group to interest rate risk are described in the table below, together with the maximum and
minimum interest rates being earned as of June 30, 2021 and June 30, 2020. The effect on profit is shown if interest rates change by
5%, in either direction, is as follows:
(in U.S. dollars, in thousands, except percent data)
Borrowings - USD
Rate increase by 5%
Rate decrease by 5%
As of
June 30, 2021
High
Low
USD
Low
As of
June 30, 2020
High
USD
9.70%
10.19%
9.22%
9.70% 52,864(1)
243
10.19%
(243)
9.22%
9.70%
10.19%
9.22%
9.70% 49,900(1)
10.19%
243
9.22%
(243)
(1)
Effect on profit/loss of interest rate changes is based on the loan principal amount of $50.0 million as of June 30, 2021 and June
30, 2020.
The Group is also exposed to interest rate movements which impacts interest income earned on its deposits and at call accounts.
The interest income derived from these balances can fluctuate due to interest rate changes. This interest rate risk is managed by
periodically reviewing interest rates available for suitable interest bearing accounts to ensure we earn interest at market rates. The
Group ensures that sufficient funds are available, in at call accounts, to meet the working capital requirements of the Group.
The deposits held which derive interest revenue are described in the table below, together with the maximum and minimum
interest rates being earned as of June 30, 2021 and June 30, 2020. The effect on profit is shown if interest rates change by 10%, in
either direction, is as follows:
(in U.S. dollars, in thousands, except percent data)
Funds invested - USD
Rate increase by 10%
Rate decrease by 10%
AUD
Funds invested - AUD
Rate increase by 10%
Rate decrease by 10%
As of
June 30, 2021
High
0.00%(1)
0.03%(1)
0.03%(1)
Low
0.00%(1)
0.03%(1)
0.03%(1)
USD
107,564
32
(32)
As of
June 30, 2020
High
Low
USD
0.03%
0.03%
0.03%
0.03% 102,925
3
0.03%
(3)
0.03%
Low
High
AUD
Low
High
AUD
0.24%
0.26%
0.22%
0.24%
0.26%
0.22%
600
0
(0)
0.86%
0.95%
0.77%
0.86%
0.95%
0.77%
600
1
(1)
(1) The interest rate reduced to 0% for the year ended June 30, 2021. The sensitivity assumes the interest rate to increase or
decrease by 0.03%, which is the opening rate on July 1, 2020.
(iii) Price risk
Price risk is the risk that future cash flows derived from financial instruments will be altered as a result of a market price
movement, which is defined as movements other than foreign currency rates and interest rates. The Group is exposed to price risk
177
which arises from long-term borrowings under its facility with NovaQuest, where the timing and amounts of principal and interest
payments is dependent on net sales of remestemcel-L for the treatment of SR-aGVHD in pediatric patients in the United States and
other territories excluding Asia. As net sales of remestemcel-L for the treatment of SR-aGVHD in pediatric patients in these territories
increase/decrease, the timing and amount of principal and interest payments relating to the financing arrangement will also fluctuate,
resulting in an adjustment to the carrying amount of financial liability. The adjustment is recognized in the Income Statement as
remeasurement of borrowing arrangements within finance costs in the period the revision is made.
The exposure of the Group’s borrowing to price rate changes are as follows:
(in U.S. dollars, in thousands, except percent data)
Financial liabilities
Current borrowings
Borrowings - NovaQuest
Non-current borrowings
Borrowings - NovaQuest
As of
June 30, 2021
As of
June 30, 2020
Total
% of total
loans
Total
% of total
loans
336
0%
4,506
41,045
41,381
45%
45%
35,072
39,578
5%
39%
44%
As at June 30, 2021, all other factors held constant, a 20% increase in the forecast net sales of remestemcel-L for the treatment
of SR-aGVHD in pediatric patients in the United States and other territories excluding Asia would increase non-current borrowing and
decrease profit by $0.2 million, whereas a 20% decrease in the net sales of remestemcel-L for the treatment of SR-aGVHD in pediatric
patients in the United States and other territories excluding Asia would decrease non-current borrowings and increase profit by $0.3
million.
The Group is also exposed to price risk on contingent consideration provision balances, as expected unit revenues are a
significant unobservable input used in the level 3 fair value measurements. As at June 30, 2021, all other factors held constant, the
increase/decrease in price assumptions adopted in the fair value measurements of the contingent consideration provision are discussed
in Note 5(g)(iv).
The Group does not consider it has any exposure to price risk other than those already described above.
b.
Credit risk
Credit risk is the risk that one party to a financial instrument will fail to discharge its obligation and cause financial loss to the
other party. The Group does not generally have trade receivables. The Group’s receivables are tabled below.
(in U.S. dollars, in thousands)
Cash and cash equivalents
Deposits at call (Note 5(a)) - minimum A rated
Cash at bank (Note 5(a)) - minimum A rated
Trade and other receivables
Receivable from other parties (non-rated)
Receivable from the Australian Government (Income Tax)
Receivable from the Australian Government (Foreign
Withholding Tax)
Receivable from minimum A rated bank deposits (interest)
Receivable from the Australian Government (Goods
and Services Tax)
Receivable from the United States Government (Income Tax)
Receivable from the Swiss Government (Value-Added Tax)
Receivable from the United States Government (U.S. tax credits)
Other non-current assets
Receivable from the United States Government (U.S. tax credits)
As of June 30,
2021
2020
451
412
136,430 128,916
2,122
—
400
257
388
3
—
1,473
801
—
400
250
171
—
2
—
—
1,473
178
c.
Liquidity risk
Liquidity risk is the risk that the Group will not be able to pay its debts as and when they fall due. Liquidity risk has been
assessed in Note 1(i).
All financial liabilities, excluding contingent consideration, borrowings and lease liabilities held by the Group as of June 30,
2021 and June 30, 2020 are non-interest bearing and mature within 6 months. The total contractual cash flows associated with these
liabilities equate to the carrying amount disclosed within the financial statements.
As of June 30, 2021, the maturity profile of the anticipated future contractual cash flows, on an undiscounted basis and which,
therefore differs from the carrying value, is as follows:
(in U.S. dollars, in thousands)
Borrowings(1)(2)
Trade payables
Lease liabilities
Contingent consideration(3)
Within
1 year
(57,378)
(19,598)
(3,373)
(1,019)
(81,368)
Between
1-2 years
Between
2-5 years
Over
5 years
(5,558)
—
(3,400)
(1,824)
(10,782)
(79,150)
—
(5,894)
(13,046)
(98,090)
—
—
—
—
—
Total
contractual
cash flows
(142,086)
(19,598)
(12,667)
(15,889)
(190,240)
Carrying
amount
(94,245)
(19,598)
(11,250)
(7,081)
(132,174)
(1) Contractual cash flows include payments of principal, interest and other charges. Interest is calculated based on debt held at
June 30, 2021 without taking into account drawdowns of further tranches.
(2)
(3)
In relation to the contractual maturities of the NovaQuest borrowings, there is variability in the maturity profile of the
anticipated future contractual cash flows given the timing and amount of payments are calculated based on our estimated net
sales of remestemcel-L for the treatment of pediatric SR-aGVHD.
In relation to the contractual maturities of the royalty payments related to contingent consideration, there is variability in the
maturity profile of the anticipated future contractual cash flows given the timing and amount of payments are calculated based
on our estimated net sales of remestemcel-L for the treatment of children and adults with aGVHD. The carrying amount reflects
the discounted and probability adjusted contractual balance. Product royalties will be payable in cash which will be funded from
royalties received from net sales. With respect to future milestone payments, contingent consideration will be payable in cash or
shares at our discretion. The carrying amount reflects the discounted and probability adjusted contractual balance related to
royalty payments.
11. Capital management
The Group’s objective when managing capital is to safeguard its ability to continue as a going concern, so that it can provide
returns for shareholders and benefits for other stakeholders. See Note 5(a) for the cash reserves of the Group as at the end of the
financial reporting period.
12. Interests in other entities
The Group’s subsidiaries as of June 30, 2021 and 2020 are set out below. Unless otherwise stated, they have share capital
consisting solely of ordinary shares that are held directly by the Group, and the proportion of ownership interests held equals the
voting rights held by the Group. The country of incorporation or registration is also their principal place of business, aside from
BeiCell Ltd, which was incorporated on November 15, 2018 in the Cayman Islands however operates in Hong Kong.
Country of
incorporation
Class of
shares
Equity holding
As of June 30,
2021
%
2020
%
Mesoblast, Inc.
Mesoblast International Sàrl (includes Mesoblast
International Sàrl Singapore Branch)
Mesoblast Australia Pty Ltd
Mesoblast UK Ltd
Mesoblast International (UK) Ltd
BeiCell Ltd
USA
Ordinary
Switzerland
Australia
United Kingdom
United Kingdom
Cayman Islands
Ordinary
Ordinary
Ordinary
Ordinary
Ordinary
100
100
100
100
100
100
100
100
100
100
100
100
179
13. Contingent assets and liabilities
a.
Contingent assets
The Group did not have any contingent assets outstanding as of June 30, 2021 and June 30, 2020.
b.
Contingent liabilities
(i) Central Adelaide Local Health Network Incorporated (“CALHNI”) (formerly Medvet)
The Group acquired certain intellectual property relating to our MPCs, or Medvet IP, pursuant to an Intellectual Property
Assignment Deed, or IP Deed, with Medvet Science Pty Ltd, or Medvet. Medvet’s rights under the IP Deed were transferred to
Central Adelaide Local Health Network Incorporated, or CALHNI, in November 2011. In connection with its use of the Medvet IP, on
completion of certain milestones the Group will be obligated to pay CALHNI, as successor in interest to Medvet, (i) certain
aggregated milestone payments of up to $2.2 million and single-digit royalties on net sales of products covered by the Medvet IP, for
cardiac muscle and blood vessel applications and bone and cartilage regeneration and repair applications, subject to minimum annual
royalties beginning in the first year of commercial sale of those products and (ii) single-digit royalties on net sales of the specified
products for applications outside the specified fields.
(ii) Other contingent liabilities
The Group has entered into a number of other agreements with other third parties pertaining to intellectual property. Contingent
liabilities may arise in the future if certain events or developments occur in relation to these agreements. As of June 30, 2021, the
Group has assessed these contingent liabilities to be remote and specific disclosure is not required.
14. Commitments
a.
Capital commitments
The Group did not have any commitments for future capital expenditure outstanding as of June 30, 2021 and June 30, 2020.
b.
Purchase commitments
In December 2019, the Group commenced production under its manufacturing service agreement with Lonza for the supply of
commercial product for the potential approval and launch of remestemcel-L for the treatment of pediatric SR-aGVHD in the US
market. As a result of receiving the Complete Response Letter from the FDA on the BLA for remestemcel-L on September 30, 2020,
in March 2021 the Group entered an agreement to reduce the remaining minimum financial commitment of its manufacturing service
with Lonza through to November 2021, with an option to extend the non-cancellable term to June 2024 at the Group’s discretion. In
June 2021, the Group exercised the option to extend the non-cancellable term of this agreement to June 2024.
This agreement contains lease and non-lease components. As of June 30, 2021, the agreement contains a minimum remaining
financial commitment of the non-lease component of $24.0 million, payable until June 2024. The Group has accounted for the lease
component within the agreement as a lease liability separately from the non-lease components. As of June 30, 2021, the lease
component is $5.0 million on an undiscounted basis, as disclosed within the total contractual cash flows as lease liabilities in Note
10(c).
The group have agreements with third parties related to contract manufacturing and other goods and services. As of June 30,
2021, the Group had $9.6 million of non-cancellable purchase commitments related to raw materials, manufacturing agreements and
other goods and services, which are expected to be paid through 2022. This amount represents our minimum contractual obligations,
including termination fees. Certain agreements provide for termination rights subject to termination fees. Under such agreement, the
Group are contractually obligated to make certain payments, mainly, to reimburse them for their unrecoverable outlays incurred prior
to cancellation.
The Group did not have any other purchase commitments as of June 30, 2021.
15. Events occurring after the reporting period
In August 2021, the Group and Hercules amended the terms of the loan and security agreement to extend the interest-only
period to January 1, 2022. Presentation at June 30, 2021 has not been changed as a result of this amendment.
180
There were no other events that have occurred after June 30, 2021 and prior to the signing of this financial report that would
likely have a material impact on the financial results presented.
16. Related party transactions
a.
Parent entity
The parent entity within the Group is Mesoblast Limited.
b.
Subsidiaries
Details of interests in subsidiaries are disclosed in Note 12 to the financial statements.
c.
Key management personnel compensation
The aggregate compensation made to Directors and other members of key management personnel of the Group is set out below
(in U.S. dollars)
Short-term employee benefits
Long-term employee benefits
Post-employment benefits
Share based payments
Year Ended June 30,
2021
2020
12,646
36,444
2,401,749 2,483,862
11,366
34,294
1,469,698 1,146,965
3,920,537 3,676,487
d.
Transactions with other related parties
Accounts receivable from revenues, accounts payable to expenses and loans from subsidiaries as at the end of the fiscal year
have been eliminated on consolidation of the Group.
e.
Terms and conditions
All other transactions were made on normal commercial terms and conditions and at market rates, except that there are no fixed
terms for the repayment of loans between the parties.
Outstanding balances are unsecured and are repayable in cash.
17. Share-based payments
The Company has adopted an Employee Share Option Plan (“ESOP”) and a Loan Funded Share Plan (“LFSP”) (together, “the
Plans”) to foster an ownership culture within the Company and to motivate senior management and consultants to achieve
performance targets. Selected directors, employees and consultants may be eligible to participate in the Plans at the absolute discretion
of the board of directors, and in the case of directors, upon approval by shareholders. The Company has not issued new securities
under the LFSP since July 1, 2015, as of December 16, 2019 all LFSP grants had reach their expiry date.
Grant policy
In accordance with the Company’s policy, options and loan funded shares are typically issued in three equal tranches. For issues
granted prior to July 1, 2015 the length of time from grant date to expiry date was typically 5 years. Grants since July 1, 2015, are
issued with a seven year term.
Options issued to employees generally vest based on performance or time conditions, or both. In the year ended June 30, 2021,
senior executives were issued options that vest based on performance and time conditions. These options are required to satisfy certain
pre-specified performance conditions and time-based vesting conditions prior to vesting. Time-based conditions restrict vesting to a
maximum of one third at 12 months, two thirds at 24 months and full grant at 36 months, but only if the pre-specified performance
conditions have been met. For time-based vesting options, the first tranche typically vests 12 months after grant date, the second
tranche 24 months after grant date, and the third tranche 36 months after grant date.
181
The exercise price is determined by reference to the Company policy. Generally the exercise price is the higher of the volume
weighted average share price of the five ASX trading days up to Board approval of the grant, and the last closing price of an ordinary
share on the ASX at Board approval. In the case of options that have time-based vesting conditions only, the board of directors adds a
10% premium to the market price. Options with performance based vesting conditions are issued with no premium. The board of
directors’ policy is not to issue options at a discount to the market price.
The aggregate number of options which may be issued pursuant to the ESOP must not exceed 10,000,000 with respect to US
incentive stock options, and with respect to Australian residents, the limit imposed under the Australian Securities and Investments
Commission Class Order 14/1000.
In addition, the LFSP which has not been issued since July 1, 2015 and as of December 16, 2019 all LFSP grants had reach their
expiry date, has the following characteristics:
On grant date, the Company issues new equity (rather than purchasing shares on market), and the loan funded shares are placed
in a trust which holds the shares on behalf of the employee. The trustee issues a limited recourse, interest free, loan to the employee
which is equal to the number of shares multiplied by the price. A limited-recourse loan means that the repayment amount will be the
lesser of the outstanding loan value (the loan value less any amounts that may have already been repaid) and the market value of the
shares that are subject to the loan. The price is the amount the employee must pay for each loan funded share if exercised.
The trustee continues to hold the shares on behalf of the employee until the employee chooses to settle the loan pertaining to the
shares and all vesting conditions have been satisfied, at which point ownership of the shares is fully transferred to the employee.
Any dividends paid by the Company, while the shares are held by the trustee, are applied as a repayment of the loan at the after-
tax value of the dividend.
182
a.
Reconciliation of outstanding share based payments
Series
32
33
34
34a
34b
35
35a
36
36a
36b
37
38
38a
39
39a
40
40a
41
42
43
43b
44
45
46
47
48
49
49
49a
49b
49c
50
50a
51
52
53
54
54
55
56
57
58
59
60
61
63
63a
64
64a
64b
64c
Granted No.
(during the
year)
Exercise
Price
Opening
Balance
Grant Date(1) Expiry Date
30-Jun-22 AUD 4.20 2,268,334
10-Jul-15
26-Aug-15 16-Aug-22 AUD 4.05
75,000
27-Apr-16 06-Mar-23 AUD 2.80 2,638,334
200,000
27-Apr-16 17-Apr-23 AUD 2.74
200,000
31-Oct-16 06-Mar-23 AUD 2.80
30-Jun-16 30-Jun-22(2) AUD 2.20
900,000
30-Jun-22 AUD 2.86
18-Jul-20
06-Dec-16 05-Dec-23 AUD 1.31
923,000
06-Dec-16 05-Dec-23 AUD 1.19 2,519,064
300,000
12-Jan-24 AUD 1.65
13-Jan-17
150,000
27-Jun-24 AUD 2.23
28-Jun-17
66,666
16-Sep-17 15-Sep-24 AUD 1.54
16-Sep-17 15-Sep-24 AUD 1.40
150,000
12-Oct-24 AUD 1.94 1,655,000
13-Oct-17
12-Oct-24 AUD 1.76 1,302,425
13-Oct-17
750,000
24-Nov-17 23-Nov-24 AUD 1.41
750,000
24-Nov-17 23-Nov-24 AUD 1.28
200,000
17-Jun-25 AUD 1.52
18-Jun-18
200,000
10-Jul-25 AUD 1.56
11-Jul-18
17-Jul-25 AUD 1.87 5,398,334
18-Jul-18
350,000
17-Jul-25 AUD 1.87
18-Jul-18
300,000
14-Jul-25 AUD 1.72
15-Jul-18
590,000
30-Nov-18 29-Nov-25 AUD 1.33
5,000
18-Jan-26 AUD 1.45
19-Jan-19
150,000
19-Jan-19
18-Jan-26 AUD 1.45
04-Apr-19 03-Apr-26 AUD 1.48
300,000
19-Jul-26 AUD 1.62 4,690,000
20-Jul-19
19-Jul-26 AUD 1.62
20-Jul-19
19-Jul-26 AUD 1.47 5,500,000
20-Jul-19
19-Jul-26 AUD 1.47 1,346,667
20-Jul-19
538,667
19-Jul-26 AUD 1.47
20-Jul-19
700,000
19-Jul-26 AUD 1.47
20-Jul-19
400,000
19-Jul-26 AUD 1.47
20-Jul-19
150,000
29-Aug-19 28-Aug-26 AUD 1.47
400,000
29-Aug-19 28-Aug-26 AUD 1.62
800,000
29-Aug-19 28-Aug-26 AUD 1.47
25-Nov-19 24-Nov-26 AUD 1.98
845,000
25-Nov-19 24-Nov-26 AUD 1.98
29-May-19 28-May-26 AUD 1.48
18-Nov-19 17-Nov-26 AUD 1.83
25-Nov-19 24-Nov-26 AUD 1.80
25-Nov-19 24-Nov-26 AUD 1.98
24-Jan-20
23-Jan-27 AUD 3.38
17-Apr-20 16-Apr-27 AUD 2.51
17-Apr-20 16-Apr-27 AUD 2.51
18-May-20 17-May-27 AUD 4.02
18-May-20 17-May-27 AUD 3.65
15-Jul-27 AUD 3.75
16-Jul-20
15-Jul-27 AUD 3.41
16-Jul-20
15-Jul-27 AUD 3.41
16-Jul-20
15-Jul-27 AUD 3.41
16-Jul-20
—
—
—
—
—
—
— 1,500,000
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
450,000
—
200,000
—
100,000
—
450,000
65,000
—
57,660
—
—
250,000
— 1,200,000
— 2,400,000
— 5,970,000
— 3,400,000
325,000
—
350,000
—
183
Exercised
No. (during
the year)
(515,000)
—
(769,355)
(116,666)
—
(900,000)
—
(300,000)
(426,668)
(300,000)
(150,000)
(16,666)
—
(565,000)
(400,000)
—
—
—
—
(944,998)
—
(150,000)
—
(1,667)
—
—
(523,661)
Lapsed/Forfeited*
No. (during
the year)
Vested and
exercisable
No (end of
year)
Closing
Balance
623,000
—
—
50,000
150,000
— 1,753,334 1,753,334
75,000
75,000
—
(10,000) 1,858,979 1,858,979
—
(83,334)
—
200,000
200,000
—
—
—
—
— 1,500,000 1,500,000
623,000
—
(141,666)* 1,950,730 1,809,064
—
—
—
—
50,000
—
—
150,000
— 1,090,000 1,090,000
902,425
—
750,000
—
—
—
200,000
—
133,334
—
(251,670)* 4,201,666 2,526,653
233,334
350,000
50,000
150,000
393,332
590,000
1,667
3,333
150,000
150,000
200,000
300,000
(6,666) 3,638,671 1,030,310
902,425
750,000
750,000
200,000
200,000
—
—
—
—
—
—
(800,002)
—
—
—
—
—
—
—
(98,334)
(100,000)
—
—
—
—
—
—
—
—
—
—
—
—
(521,002)*
(700,000)* 3,999,998
— 1,346,667
538,667
—
700,000
—
400,000
—
150,000
—
400,000
—
800,000
—
(11,667)
295,000
(439,999)*
—
—
—
—
(55,000)*
(57,660)*
(200,000)*
350,000
200,000
100,000
450,000
10,000
—
50,000
— 1,200,000
— 2,400,000
(1,690,000)* 4,280,000
(350,000)* 3,050,000
325,000
350,000
—
—
400,001
448,889
179,556
—
—
—
133,333
266,667
98,334
300,000
66,666
100,000
150,000
3,333
—
16,666
400,000
—
—
—
—
—
15-Jul-27 AUD 3.41
16-Jul-20
15-Jul-27 AUD 3.41
16-Jul-20
26-Aug-20 25-Aug-27 AUD 5.76
11-Sep-20 10-Sep-27 AUD 4.78
08-Oct-20
07-Oct-27 AUD 3.84
20-Nov-20 19-Nov-27 AUD 3.60
20-Nov-20 19-Nov-27 AUD 3.60
17-Feb-21 16-Feb-28 AUD 2.67
30-Jun-21 30-Aug-21 AUD 0.00
64d
64e
65
66
67
68
69
71
73
June 30, 2021
Weighted average share purchase price
—
300,000
— 1,200,000
140,000
—
200,000
—
240,000
—
200,000
—
100,000
—
250,000
—
45,746
—
—
—
—
—
—
—
—
—
—
38,911,491 18,193,406 (7,078,017)
AUD 1.86 AUD 3.56 AUD 2.06
—
300,000
— 1,200,000
5,000
200,000
200,000
200,000
100,000
250,000
45,746
—
—
—
—
—
—
100,000
—
45,746
(4,693,664) 45,333,216 18,389,623
AUD 2.42 AUD 2.15
AUD 2.76
(135,000)*
—
(40,000)*
—
—
—
—
(1)
The dates presented in the grant date column represent the date on which board approval was obtained. For valuation dates per
IFRS 2, refer to Note 17(c).
(2) Based on the amended terms, the incentive rights granted pursuant to the Equity Facility Agreement with Kentgrove Capital,
dated June 30, 2016, will expire thirty six months after the effective date, July 1, 2019.
184
Series
Exercise
Grant Date(1) Expiry Date
Price
USD 0.340
26-Oct-19
07-Dec-10
AUD 4.49
31-Oct-19
12-Dec-14
09-Oct-14
AUD 4.52
08-Oct-19
24-Nov-19 AUD 4.00
25-Nov-14
16-Dec-19 AUD 4.66
06-Jan-15
16-Feb-20 AUD 4.28
12-May-15
10-Jul-15
AUD 4.20
30-Jun-22
16-Aug-22 AUD 4.05
26-Aug-15
06-Mar-23 AUD 2.80
27-Apr-16
06-Mar-23 AUD 2.80
27-Apr-16
27-Apr-16
17-Apr-23 AUD 2.74
06-Mar-23 AUD 2.80
31-Oct-16
18-Jan-21
30-Jun-16
AUD 2.20
05-Dec-23 AUD 1.31
06-Dec-16
05-Dec-23 AUD 1.19
06-Dec-16
AUD 1.65
12-Jan-24
13-Jan-17
27-Jun-24
28-Jun-17
AUD 2.23
15-Sep-24 AUD 1.54
16-Sep-17
15-Sep-24 AUD 1.40
16-Sep-17
12-Oct-24 AUD 1.94
13-Oct-17
13-Oct-17
12-Oct-24 AUD 1.76
23-Nov-24 AUD 1.41
24-Nov-17
23-Nov-24 AUD 1.28
24-Nov-17
AUD 1.52
17-Jun-25
18-Jun-18
AUD 1.56
10-Jul-25
11-Jul-18
AUD 1.87
17-Jul-25
18-Jul-18
AUD 1.87
17-Jul-25
18-Jul-18
AUD 1.87
17-Jul-25
18-Jul-18
15-Jul-18
AUD 1.72
14-Jul-25
29-Nov-25 AUD 1.33
30-Nov-18
AUD 1.45
18-Jan-26
19-Jan-19
AUD 1.45
18-Jan-26
19-Jan-19
03-Apr-26 AUD 1.48
04-Apr-19
AUD 1.62
19-Jul-26
20-Jul-19
AUD 1.47
19-Jul-26
20-Jul-19
AUD 1.47
19-Jul-26
20-Jul-19
AUD 1.47
19-Jul-26
20-Jul-19
AUD 1.47
19-Jul-26
20-Jul-19
20-Jul-19
AUD 1.47
19-Jul-26
28-Aug-26 AUD 1.47
29-Aug-19
28-Aug-26 AUD 1.62
29-Aug-19
28-Aug-26 AUD 1.47
29-Aug-19
24-Nov-26 AUD 1.98
25-Nov-19
28-May-26 AUD 1.48
29-May-19
17-Nov-26 AUD 1.83
18-Nov-19
24-Nov-26 AUD 1.80
25-Nov-19
24-Nov-26 AUD 1.98
25-Nov-19
INC
25b
28/LF13
29
LF14
31b
32
33
34
34
34a
34b
35
36
36a
36b
37
38
38a
39
39a
40
40a
41
42
43
43
43b
44
45
46
47
48
49
49a
49b
49c
50
50a
51
52
53
54
55
56
57
58
June 30, 2020
Weighted average share purchase price
Opening
Balance
Granted No.
(during the
year)
Exercised
No. (during
the year)
Lapsed
/Forfeited*
No. (during
the year)
319,892
50,000
75,000
240,000
150,000
200,000
2,308,334
75,000
3,193,334
200,000
200,000
1,500,000
1,670,000
4,188,000
300,000
150,000
100,000
150,000
1,978,333
1,900,000
750,000
750,000
200,000
200,000
5,845,000
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
(319,892)
—
—
—
—
—
—
—
(475,000)
—
—
(600,000)
(720,334)
(1,527,270)
—
—
(33,334)
—
(310,000)
(297,575)
—
—
—
—
(389,999)
Vested and
exercisable
No (end of
year)
—
—
—
—
—
—
2,268,334
75,000
2,638,334
200,000
200,000
900,000
923,000
2,023,232
300,000
150,000
33,334
150,000
999,994
1,302,425
500,000
—
133,334
66,667
1,544,992
Closing
Balance
—
—
—
—
—
—
2,268,334
75,000
2,638,334
200,000
200,000
900,000
923,000
2,519,064
300,000
150,000
66,666
150,000
1,655,000
1,302,425
750,000
750,000
200,000
200,000
5,398,334
116,667
350,000
—
100,000
—
300,000
196,666
—
590,000
1,667
—
5,000
150,000
—
150,000
100,000
300,000
—
—
4,810,000
—
—
5,500,000
—
—
1,346,667
—
—
538,667
—
—
700,000
—
—
400,000
—
—
300,000
—
—
400,000
—
—
800,000
—
—
845,000
—
300,000
450,000
—
—
200,000
—
—
100,000
—
—
450,000
—
27,737,893 17,490,334
(1,493,332) 38,911,491 15,373,646
AUD 2.06 AUD 1.57 AUD 1.60 AUD 2.80 AUD 1.86 AUD 2.25
—
—
—
—
—
—
—
—
—
—
—
—
(150,000)
—
—
—
—
—
—
—
(4,823,404)
350,000
300,000
590,000
5,000
150,000
300,000
4,690,000
5,500,000
1,346,667
538,667
700,000
400,000
150,000
400,000
800,000
845,000
450,000
200,000
100,000
450,000
—
(50,000)
(75,000)
(240,000)
(150,000)
(200,000)
(40,000)
—
(70,000)
(10,000) *
—
—
—
(26,666)
(141,666)
—
—
—
—
(13,333)
(300,000)
—
—
—
—
(9,999)
(46,668) *
—
—
—
—
—
—
(120,000) *
—
—
—
—
—
—
—
—
—
—
—
—
—
(1)
(2)
The dates presented in the grant date column represent the date on which board approval was obtained. For valuation dates per
IFRS 2, refer to Note 17(c).
30a to 30i were granted as remuneration for the repurchase and cancellation of 2,985,000 LFSP during the year ended 30 June
2015 (see Note 17(b)).
185
Exercise
Price
Opening
Balance
Granted No.
(during the
year)
Exercised
No. (during
the year)
Lapsed
/Forfeited*
No. (during
the year)
Vested and
exercisable
No (end of
year)
—
319,892
—
—
—
50,000
Closing
Balance
—
319,892
—
—
—
50,000
Series
Grant Date(1) Expiry Date
07-Dec-10
07-Dec-10
09-Jul-12
04-Sep-13
01-Jan-14
12-Dec-14
05-Sep-14
05-Sep-14
09-Oct-14
25-Nov-14
25-Mar-15
25-Mar-15
25-Mar-15
25-Mar-15
25-Mar-15
06-Jan-15
12-May-15
10-Jul-15
26-Aug-15
27-Apr-16
27-Apr-16
31-Oct-16
30-Jun-16
06-Dec-16
06-Dec-16
13-Jan-17
28-Jun-17
16-Sep-17
16-Sep-17
13-Oct-17
13-Oct-17
24-Nov-17
24-Nov-17
18-Jun-18
11-Jul-18
18-Jul-18
15-Jul-18
30-Nov-18
19-Jan-19
19-Jan-19
INC
INC
17/LF3
22/LF8
25a (i&ii)
25b
27/LF12
27/LF12
28/LF13
29
30c(2)
30d(2)
30f(2)
30h(2)
30i(2)
LF14
31b
32
33
34
34a
34b
35
36
36a
36b
37
38
38a
39
39a
40
40a
41
42
43
44
45
46
47
June 30, 2019
Weighted average share purchase price
26-Oct-18 USD 0.305
26-Oct-19 USD 0.340
AUD 6.67
08-Jul-18
27-Aug-18 AUD 6.26
31-Dec-18 AUD 6.36
31-Oct-19 AUD 4.49
AUD 4.71
30-Jun-19
30-Jun-19
AUD 4.71
08-Oct-19 AUD 4.52
24-Nov-19 AUD 4.00
AUD 4.98
20-Jan-19
AUD 4.98
25-Jan-19
AUD 4.98
25-Jan-19
AUD 4.69
30-Jun-19
30-Jun-19
AUD 4.44
16-Dec-19 AUD 4.66
16-Feb-20 AUD 4.28
AUD 4.20
30-Jun-22
16-Aug-22 AUD 4.05
06-Mar-23 AUD 2.80
17-Apr-23 AUD 2.74
06-Mar-23 AUD 2.80
AUD 2.20
18-Jan-21
05-Dec-23 AUD 1.31
05-Dec-23 AUD 1.19
AUD 1.65
12-Jan-24
AUD 2.23
27-Jun-24
15-Sep-24 AUD 1.54
15-Sep-24 AUD 1.40
12-Oct-24 AUD 1.94
12-Oct-24 AUD 1.76
23-Nov-24 AUD 1.41
23-Nov-24 AUD 1.28
AUD 1.52
17-Jun-25
AUD 1.56
10-Jul-25
AUD 1.87
17-Jul-25
AUD 1.72
14-Jul-25
29-Nov-25 AUD 1.33
AUD 1.45
18-Jan-26
AUD 1.45
18-Jan-26
26,108
319,892
150,000
225,000
650,000
50,000
2,045,000
—
—
(150,000)
(225,000)
(650,000)
—
(1,790,000)
(255,000) *
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
200,000
200,000
5,970,000
300,000
590,000
5,000
150,000
7,415,000
75,000
240,000
135,000
300,000
200,000
400,000
600,000
150,000
200,000
2,458,334
75,000
3,380,000
200,000
200,000
1,500,000
1,885,000
4,400,000
300,000
300,000
100,000
150,000
2,215,000
1,900,000
750,000
750,000
—
75,000
240,000
—
—
—
—
—
150,000
200,000
2,308,334
75,000
3,193,334
200,000
200,000
1,500,000
1,116,666
3,000,502
300,000
100,000
33,334
150,000
668,330
1,300,000
250,000
—
66,667
—
—
—
—
—
75,000
(5,693,333) 27,737,893 15,572,059
26,329,334
AUD 2.68 AUD 1.79 AUD 1.16 AUD 4.58 AUD 2.06 AUD 2.35
—
75,000
240,000
—
—
—
—
—
150,000
200,000
2,308,334
75,000
3,193,334
200,000
200,000
1,500,000
1,670,000
4,188,000
300,000
150,000
100,000
150,000
1,978,333
1,900,000
750,000
750,000
200,000
200,000
5,845,000
300,000
590,000
5,000
150,000
(135,000)
(300,000)
(200,000)
(400,000)
(600,000)
—
—
(150,000) *
—
(186,666) *
—
—
—
(140,000) *
—
—
(150,000) *
—
—
(236,667) *
—
—
—
—
—
(125,000) *
—
—
—
—
(26,108)
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
(75,000)
(212,000)
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
(313,108)
(1)
(2)
The dates presented in the grant date column represent the date on which board approval was obtained. For valuation dates per
IFRS 2, refer to Note 17(c).
30a to 30i were granted as remuneration for the repurchase and cancellation of 2,985,000 LFSP during the year ended 30 June
2015 (see Note 17(b)).
186
The weighted average share price at the date of exercise of options exercised during the years ended June 30, 2021, 2020 and
2019 were AUD 4.42, AUD 3.47 and AUD 2.06 respectively. The weighted average remaining contractual life of share options and
loan funded shares outstanding as of June 30, 2021, 2020 and 2019 were 4.49 years, 4.79 years and 4.53 years, respectively.
b.
Existing share-based payment arrangements
General terms and conditions attached to share based payments
Share options pursuant to the employee share option plan are generally granted in three equal tranches. For issues granted prior
to July 1, 2015 the length of time from grant date to expiry date was typically 5 years. Grants since July 1, 2015, are issued with a
seven year term. Vesting occurs based on achievement of performance conditions and/or progressively over the life of the option with
the first tranche vesting one year from grant date, the second tranche two years from grant date, and the third tranche three years from
grant date. On cessation of employment the Company’s board of directors determines if a leaver is a bad leaver or not. If a participant
is deemed a bad leaver, all rights, entitlements and interests in any unexercised options or shares (pursuant to the loan funded share
plan) held by the participant will be forfeited and will lapse immediately. If a leaver is not a bad leaver they may retain vested options
and shares (pursuant to the loan funded share plan), however, they must be exercised within 60 days of cessation of employment (or
within a longer period if so determined by the Company’s board of directors), after which time they will lapse. Unvested options will
normally be forfeited and lapse.
This policy applies to all issues shown in the above table with the exception of the following:
25a(i&ii)
INC.
31b
35
35a
Options were granted in two equal tranches and vested on the date that the option holder had direct involvement (to
the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential
commercial objectives.
As part of the acquisition of Mesoblast, Inc., Mesoblast, Inc. options were converted to options of the Company at
a conversion ratio of 63.978. The Mesoblast, Inc. option exercise price per option was adjusted using the same
conversion ratio. All options vested on acquisition date (December 7, 2010), and will expire according to their
original expiry dates (with the exception of options held by directors which were limited to an expiry date not
exceeding four years from acquisition).
Options were granted in two equal tranches and will vest on the date that the option holder has direct involvement
(to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential
commercial objectives.
Incentive rights granted pursuant to the Equity Facility Agreement with Kentgrove Capital, dated June 30, 2016,
had fully vested on the agreement date and will expire thirty six months after the date of the issue of the incentive
right. The terms of this agreement were amended on July 30, 2019. Under the amended terms, these incentive
rights will expire thirty six months after the effective date of July 1, 2019.
Additional incentive rights granted pursuant to the Amendment Deed of the Equity Facility Agreement with
Kentgrove Capital, dated July 30, 2019, had fully vested on the agreement date and will expire thirty six months
after the date of the issue of the incentive right.
36a & 36b
Options were granted in two or three equal tranches and will vest on the date that the option holder has direct
involvement (to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain
confidential commercial objectives.
49a, 49b, 50,
50a, 53, 64b,
64c, 64d, 64e &
71
Options were granted two or three equal tranches and are required to satisfy certain pre-specified performance
conditions and time-based vesting conditions prior to vesting. Time-based conditions restrict vesting to a maximum
of one third at 12 months, two thirds at 24 months and full grant at 36 months, but only if the pre-specified
performance conditions have been met.
38a, 40a, 57 &
66
Options were granted in one tranche and will vest on the date that the option holder has direct involvement (to the
reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential
commercial objectives.
39a
Options were granted in one or two equal tranches and will vest on the date that the option holder has direct
involvement (to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain
confidential commercial objectives.
187
51
55
63a
64a
Options were granted in two equal tranches and will vest on the date that the option holder has direct involvement
(to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential
commercial objectives.
Options were granted in five tranches and will vest on the date that the option holder has direct involvement (to the
reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential
commercial objectives.
Options were granted in three or eight tranches and will vest on the date that the option holder has direct
involvement (to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain
confidential commercial objectives. Time-based conditions restrict vesting to a maximum of one third at 12
months, two thirds at 24 months and full grant at 36 months, but only if the pre-specified performance conditions
have been met.
Options were granted in one, two, three or five tranches and will vest on the date that the option holder has direct
involvement (to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain
confidential commercial objectives. Time-based conditions restrict vesting to a maximum of one third at 12
months, two thirds at 24 months and full grant at 36 months, but only if the pre-specified performance conditions
have been met.
69 & 73
Options were granted in one tranche and vested on the date on which board approval was obtained
Modifications to share-based payment arrangements
There were no modifications made to share-based payment arrangements during the years ended June 30, 2019, June 30,
2020,and June 30, 2021.
c.
Fair values of share based payments
The weighted average fair value of share options granted during the years ended June 30, 2021, 2020 and 2019 were AUD 1.42,
AUD 1.07 and AUD 0.95, respectively.
The fair value of all shared-based payments made has been calculated using the Black-Scholes model. This model requires the
following inputs:
Share price at acceptance date
The share price used in valuation is the share price at the date at which the entity and the employee agree to a share-based
payment arrangement, being when the entity and the employee have a shared understanding of the terms and conditions of the
arrangement. This price is generally the volume weighted average share price for the five trading days leading up to the date.
Exercise price
The exercise price is a known value that is contained in the agreements.
Share price volatility
The model requires the Company’s share price volatility to be measured. In estimating the expected volatility of the underlying
shares our objective is to approximate the expectations that would be reflected in a current market or negotiated exchange price for the
option. Historical volatility data is considered in determining expected future volatility.
Life of the option
The life is generally the time period from grant date through to expiry. Certain assumptions have been made regarding “early
exercise” i.e. options exercised ahead of the expiry date, with respect to option series 14 and later. These assumptions have been based
on historical trends for option exercises within the Company and take into consideration exercise trends that are also evident as a
result of local taxation laws.
188
Dividend yield
The Company has yet to pay a dividend so it has been assumed the dividend yield on the shares underlying the options will be
0%.
Risk free interest rate
This has been sourced from the Reserve Bank of Australia historical interest rate tables for government bonds.
Model inputs
The model inputs for the valuations of options approved and granted during the year ended June 30, 2021 are as follows:
Series
61
63
63a
64
64a
64b
64c
64d
64e
65
66
67
68
69
71
73
Valuation date(1)
28-Jul-20
08-Apr-21
05-Jul-21
28-Jul-20
05-Jul-21
30-Jun-21
25-Nov-20
30-Jun-21
05-Jul-21
25-Sep-20
16-Oct-20
10-Nov-20
24-Dec-20
24-Dec-20
29-Mar-21
30-Jun-21
Exercise
price per share
AUD
2.51
4.02
3.65
3.75
3.41
3.41
3.41
3.41
3.41
5.76
4.78
3.84
3.60
3.60
2.67
0.00
Share price at
acceptance date
AUD
3.60
2.21
2.03
3.60
2.03
2.09
4.12
2.09
2.03
5.02
3.24
3.22
2.38
2.38
2.35
2.09
Expected share
price volatility
60.95%
66.74%
66.45%
60.95%
66.45%
66.48%
65.36%
66.48%
66.45%
63.16%
65.17%
65.06%
67.22%
67.22%
66.81%
66.48%
Life(2)
6.1 yrs
5.5 yrs
5.3 yrs
6.3 yrs
5.5 yrs
5.5 yrs
6.0 yrs
5.5 yrs
5.5 yrs
6.3 yrs
6.3 yrs
6.3 yrs
6.3 yrs
6.3 yrs
6.2 yrs
0.2 yrs
Dividend yield
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
Risk-free
interest rate
0.44%
0.65%
0.72%
0.44%
0.72%
0.77%
0.30%
0.77%
0.72%
0.34%
0.27%
0.30%
0.35%
0.35%
0.66%
0.77%
(1) Valuation date is the date at which the entity and the employee agree to a share-based payment arrangement, being when the
entity and the employee have a shared understanding of the terms and conditions of the arrangement.
Expected life after factoring likely early exercise.
(2)
The closing share market price of an ordinary share of Mesoblast Limited on the ASX as of June 30, 2021 was AUD 1.98.
189
The model inputs for the valuations of options approved and granted during the year ended June 30, 2020 are as follows:
Series
43b
49
49a
49a
49b
49c
50
50a
51
52
53
54
56
57
58
59
60
Valuation date(1)
14-May-20
17-Sep-19
15-Mar-20
17-Dec-19
27-Nov-19
27-Nov-19
13-Sep-19
16-Sep-19
28-Mar-20
17-Dec-19
26-Mar-20
28-Jan-20
27-Nov-19
25-Nov-19
10-Apr-20
24-May-20
25-May-20
Exercise
price per share
AUD
1.87
1.62
1.47
1.47
1.47
1.47
1.47
1.47
1.47
1.62
1.47
1.98
1.83
1.80
1.98
3.38
2.51
Share price at
acceptance date
AUD
3.55
1.93
1.87
1.93
1.83
1.83
1.88
2.03
1.17
1.93
1.17
2.86
1.83
1.80
1.97
3.79
3.79
Expected share
price volatility
60.39%
54.10%
55.48%
53.65%
53.85%
53.85%
54.02%
54.21%
55.60%
53.65%
58.30%
56.63%
53.80%
53.82%
57.65%
60.56%
60.56%
Life(2)
4.5 yrs
6.1 yrs
5.8 yrs
5.9 yrs
6.3 yrs
6.3 yrs
6.1 yrs
6.1 yrs
5.7 yrs
6.0 yrs
5.8 yrs
6.1 yrs
6.3 yrs
6.3 yrs
5.9 yrs
6.0 yrs
6.2 yrs
Dividend yield
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
Risk-free
interest rate
0.37%
0.89%
0.56%
0.82%
0.73%
0.73%
0.93%
0.95%
0.45%
0.82%
0.47%
0.71%
0.73%
0.82%
0.45%
0.40%
0.40%
(1) Valuation date is the date at which the entity and the employee agree to a share-based payment arrangement, being when the
entity and the employee have a shared understanding of the terms and conditions of the arrangement.
Expected life after factoring likely early exercise.
(2)
The closing share market price of an ordinary share of Mesoblast Limited on the ASX as of June 30, 2020 was AUD 3.25.
The model inputs for the valuations of options approved and granted during the year ended June 30, 2019 are as follows:
Series
41
43
44
45
46
47
48
55
Valuation date(1)
03-Sep-18
24-Oct-18
17-Jan-19
20-Dec-18
07-Jun-19
04-Jun-19
04-Apr-19
29-May-19
Exercise
price per share
AUD
1.52
1.87
1.72
1.33
1.45
1.45
1.48
1.48
Share price at
acceptance date
AUD
1.52
1.70
1.59
1.33
1.33
1.33
1.49
1.48
Expected share
price volatility
52.31%
52.78%
54.40%
54.11%
53.92%
53.95%
54.22%
53.98%
Life(2)
5.8 yrs
5.9 yrs
5.6 yrs
6.1 yrs
5.8 yrs
5.8 yrs
6.1 yrs
6.3 yrs
Dividend yield
0%
0%
0%
0%
0%
0%
0%
0%
Risk-free
interest rate
2.16%
2.27%
1.91%
2.01%
1.14%
1.19%
1.50%
1.18%
(1) Valuation date is the date at which the entity and the employee agree to a share-based payment arrangement, being when the
entity and the employee have a shared understanding of the terms and conditions of the arrangement.
Expected life after factoring likely early exercise.
(2)
The closing share market price of an ordinary share of Mesoblast Limited on the ASX as of June 30, 2019 was AUD 1.48.
190
18. Remuneration of auditors
During the year the following fees were paid or payable for services provided by the auditor of the parent entity, its related
practices and non-related audit firms:
(in U.S. dollars)
a. PricewaterhouseCoopers Australia
Audit and other assurance services
Audit and review of financial reports
Other audit services(1)
Total remuneration of PricewaterhouseCoopers Australia
b. Network firms of PricewaterhouseCoopers Australia
Audit and other assurance services
Audit and review of financial reports
Total remuneration of Network firms of
PricewaterhouseCoopers Australia
Total auditors' remuneration(2)
2021
Year Ended June 30,
2020
2019
747,783
91,750
839,533
713,461
14,097
727,558
690,245
—
690,245
130,450
108,262
89,038
130,450
969,983
108,262
835,820
89,038
779,283
(1) Other audit services relates to services performed in connection with the filing of registration statements on the Form S-8 and F-
3.
(2) All services provided are considered audit services for the purpose of SEC classification.
191
19. Losses per share
(Losses) per share
(in cents)
(a) Basic (losses) per share
From continuing operations attributable to the ordinary
equity holders of the company
Total basic (losses) per share attributable to the ordinary
equity holders of the company
(b) Diluted (losses) per share
From continuing operations attributable to the ordinary
equity holders of the company
Total basic (losses) per share attributable to the ordinary
equity holders of the company
2021
Years Ended June 30,
2020
2019
(16.33)
(14.74)
(18.16)
(16.33)
(14.74)
(18.16)
(16.33)
(14.74)
(18.16)
(16.33)
(14.74)
(18.16)
(c) Reconciliation of (losses) used in calculating (losses) per share
(in U.S. dollars, in thousands)
Basic (losses) per share
(Losses) attributable to the ordinary equity holders of the
company used in calculating basic (losses) per share:
From continuing operations
(98,811)
(77,940)
(89,799)
Diluted (losses) per share
(Losses) from continuing operations attributable to the
ordinary equity holders of the company:
Used in calculating basic (losses) per share
(Losses) attributable to the ordinary equity holders of the
company used in calculating diluted losses per share
Weighted average number of ordinary shares used as the
denominator in calculating basic losses per share
Weighted average number of ordinary shares and
potential ordinary shares used in calculating
diluted losses per share
(98,811)
(77,940)
(89,799)
(98,811)
(77,940)
(89,799)
2021
Number
2020
Number
2019
Number
605,064,036
528,821,630 494,381,490
605,064,036
528,821,630 494,381,490
Options granted to employees (see Note 17) are considered to be potential ordinary shares. These securities have been excluded
from the determination of basic losses per shares. Shares that may be paid as contingent consideration have also been excluded from
basic losses per share. They have also been excluded from the calculation of diluted losses per share because they are anti-dilutive for
the years ended June 30, 2021, 2020 and 2019.
192
20. Parent entity financial information
a.
Summary financial information
The parent entity financial information disclosure is an Australian Disclosure Requirement as required by Corporations
Regulations 2001. The individual financial statements for the parent entity show the following aggregate amounts:
(in U.S. dollars, in thousands)
Balance Sheet
Current Assets
Total Assets
Current Liabilities
Total Liabilities
Shareholders' Equity
Issued Capital
Reserves
Foreign Currency Translation Reserve
Share Options Reserve
Warrant Reserve
(Accumulated losses)/retained earnings
Loss for the period
Total comprehensive loss for the period
As of June 30,
2021
2020
21,135
943,030
22,715
775,407
9,136
13,904
11,765
17,278
1,163,165
1,051,450
(150,306)
77,310
12,969
(174,012)
929,126
(216,440)
69,695
—
(146,576)
758,129
(27,436)
(27,436)
(16,981)
(16,981)
b.
Contingent liabilities of the parent entity
(i) Central Adelaide Local Health Network Incorporated (“CALHNI”) (formerly Medvet)
Mesoblast Limited acquired certain intellectual property relating to our MPCs, or Medvet IP, pursuant to an Intellectual
Property Assignment Deed, or IP Deed, with Medvet Science Pty Ltd, or Medvet. Medvet’s rights under the IP Deed were transferred
to Central Adelaide Local Health Network Incorporated, or CALHNI, in November 2011. In connection with its use of the Medvet IP,
on completion of certain milestones Mesoblast Limited will be obligated to pay CALHNI, as successor in interest to Medvet, (i)
certain aggregated milestone payments of up to $2.2 million and single-digit royalties on net sales of products covered by the Medvet
IP, for cardiac muscle and blood vessel applications and bone and cartilage regeneration and repair applications, subject to minimum
annual royalties beginning in the first year of commercial sale of those products and (ii) single-digit royalties on net sales of the
specified products for applications outside the specified fields.
21. Segment information
Operating segments are identified on the basis of whether the allocation of resources and/or the assessment of performance of a
particular component of the Company’s activities are regularly reviewed by the Company’s chief operating decision maker as a
separate operating segment. By these criteria, the activities of the Company are considered to be one segment being the development
of cell technology platform for commercialization, and the segmental analysis is the same as the analysis for the Company as a whole.
The chief operating decision maker (Chief Executive Officer) reviews the consolidated income statement, balance sheet, and statement
of cash flows regularly to make decisions about the Company’s resources and to assess overall performance.
22. Legal proceedings
In October 2020, in light of the Complete Response Letter released by the FDA and the decline in the market price of our ADS,
a purported class action lawsuit was filed in the U.S Federal District Court for the Southern District of New York on behalf of
purchasers or acquirers of our ADS against the Company, its Chief Executive Officer, its Chief Financial Officer and its Chief
Medical Officer for alleged violations of the U.S. Securities Exchange Act of 1934. The Company will vigorously defend this and any
other similarly-based litigation should it arise. The Company cannot provide any assurance as to the possible outcome or cost to us
from the lawsuit, particularly as it is at an early stage, nor how long it may take to resolve such lawsuit. Thus, the Company has not
accrued any amounts in connection with such legal proceedings other than ongoing attorney’s fees.
193
23. Summary of significant accounting policies
This note provides the principal accounting policies adopted in the preparation of these consolidated financial statements as set
out below. These policies have been consistently applied to all the years presented, unless otherwise stated. The financial statements
are for the consolidated entity consisting of Mesoblast Limited and its subsidiaries.
a.
Change in accounting policies
There were no new accounting policies adopted by the Group in the year ended June 30, 2021. These financial statements follow
the same accounting policies as compared to the June 30, 2020 consolidated financial statements and related notes as filed with the
Australian Securities Exchange and the Securities and Exchange Commission.
b.
i.
Principles of consolidation
Subsidiaries
The consolidated financial statements incorporate the assets and liabilities of all subsidiaries of Mesoblast Limited (“Company”
or “Parent Entity”) as of June 30, 2021 and the results of all subsidiaries for the year then ended. Mesoblast Limited and its
subsidiaries together are referred to in this financial report as the Group or the consolidated entity.
Subsidiaries are all entities (including structured entities) over which the Group has control. The Group controls an entity when
the Group is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns
through its power to direct the activities of the entity.
Subsidiaries are fully consolidated from the date on which control is transferred to the Group. They are deconsolidated from the
date that control ceases.
The acquisition method of accounting is used to account for business combinations by the Group.
Intercompany transactions, balances and unrealized gains on transactions between Group companies are eliminated. Unrealized
losses are also eliminated unless the transaction provides evidence of the impairment of the asset transferred. Accounting policies of
subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Group.
ii.
Employee share trust
The Group has formed a trust to administer the Group’s employee share scheme. This trust is consolidated, as the substance of
the relationship is that the trust is controlled by the Group.
c.
Segment reporting
The Group operates in one segment as set out in Note 21.
d.
(i)
Foreign currency translation
Functional and presentation currency
Items included in the financial statements of each of the Group’s entities are measured using the currency of the primary
economic environment in which the entity operates (the “functional currency”). The functional currency of Mesoblast Limited is the
AUD. The consolidated financial statements are presented in USD, which is the Group’s presentation currency.
(ii)
Translations and balances
Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the
transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the transaction at period
end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in net loss, except when they
are deferred in equity as qualifying cash flow hedges and qualifying net investment hedges or attributable to part of the net investment
in a foreign operation.
Non-monetary items that are measured at fair value in a foreign currency are translated using the exchange rates at the date
when the fair value was determined. Translation differences on assets and liabilities carried at fair value are reported as part of the fair
value gain or loss. For example, translation differences on non-monetary assets and liabilities such as equities held at fair value
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through profit or loss are recognized in net loss as part of the fair value gain or loss and translation differences on non-monetary assets
such as equities classified as financial assets at fair value are recognized in other comprehensive income.
(iii) Group companies
The results and financial position of all the Group entities (none of which has the currency of a hyperinflationary economy) that
have a functional currency different from the presentation currency are translated into the presentation currency as follows:
assets and liabilities for the balance sheets presented are translated at the closing rate at the date of that balance sheets;
income and expenses for the statements of comprehensive income are translated at average exchange rates (unless this is
not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case
income and expenses are translated at the dates of the transactions); and all resulting exchange differences are recognized
in other comprehensive income.
•
•
(iv) Other
On consolidation, exchange differences arising from the translation of any net investment in foreign entities, and of borrowings
and other financial instruments designated as hedges of such investments, are recognized in other comprehensive income. When a
foreign operation is sold or any borrowings forming part of the net investment are repaid, the associated exchange differences are
reclassified to net loss, as part of the gain or loss on sale.
Goodwill and fair value adjustments arising on the acquisition of a foreign entity are treated as assets and liabilities of the
foreign entities and translated at the closing rate.
e.
Revenue recognition
The Group adopted IFRS 15 Revenue from Contracts with Customers on July 1, 2018, using the modified retrospective
approach. Revenue from contracts with customers is measured and recognized in accordance with the five step model prescribed by
the standard.
First, contracts with customers within the scope of IFRS 15 are identified. Distinct promises within the contract are identified as
performance obligations. The transaction price of the contract is measured based on the amount of consideration the Group expect to
be entitled from the customer in exchange for goods or services. Factors such as requirements around variable consideration,
significant financing components, noncash consideration, or amounts payable to customers also determine the transaction price. The
transaction is then allocated to separate performance obligations in the contract based on relative standalone selling prices. Revenue is
recognized when, or as, performance obligations are satisfied, which is when control of the promised good or service is transferred to
the customer.
There was no cumulative impact of the adoption of IFRS 15 Revenue from Contracts with Customers on July 1, 2018.
Revenues from contracts with customers comprise commercialization and milestone revenue. The Group also have revenue
from research and development tax incentives and interest revenue.
(i)
Commercialization and milestone revenue
Commercialization and milestone revenue generally includes non-refundable upfront license and collaboration fees; milestone
payments, the receipt of which is dependent upon the achievement of certain clinical, regulatory or commercial milestones; as well as
royalties on product sales of licensed products, if and when such product sales occur; and revenue from the supply of products.
Payment is generally due on standard terms of 30 to 60 days.
Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue or deferred consideration
in our consolidated balance sheets, depending on the nature of arrangement. Amounts expected to be recognized as revenue within the
12 months following the balance sheet date are classified within current liabilities. Amounts not expected to be recognized as revenue
within the 12 months following the balance sheet date are classified within non-current liabilities.
Milestone revenue
The Group applies the five-step method under the standard to measure and recognize milestone revenue.
The receipt of milestone payments is often contingent on meeting certain clinical, regulatory or commercial targets, and is
therefore considered variable consideration. The Group estimate the transaction price of the contingent milestone using the most likely
195
amount method. The Group include in the transaction price some or all of the amount of the contingent milestone only to the extent
that it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the
uncertainty associated with the contingent milestone is subsequently resolved. Milestone payments that are not within the control of
the Company, such as regulatory approvals, are not considered highly probable of being achieved until those approvals are received.
Any changes in the transaction price are allocated to all performance obligations in the contract unless the variable consideration
relates only to one or more, but not all, of the performance obligations.
When consideration for milestones is a sale-based or usage-based royalty that arises from licenses of IP (such as cumulative net
sales targets), revenue is recognized at the later of when (or as) the subsequent sale or usage occurs, or when the performance
obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Licenses of intellectual property
When licenses of IP are distinct from other goods or services promised in the contract, the Group recognize the transaction price
allocated to the license as revenue upon transfer of control of the license to the customer. The Group evaluate all other promised goods
or services in the license agreement to determine if they are distinct. If they are not distinct, they are combined with other promised
goods or services to create a bundle of promised goods or services that is distinct.
The transaction price allocated to the license performance obligation is recognized based on the nature of the license
arrangement. The transaction price is recognized over time if the nature of the license is a “right to access” license. This is when the
Group undertake activities that significantly affect the IP to which the customer has rights, the rights granted by the license directly
expose the customer to any positive or negative effects of our activities, and those activities do not result in the transfer of a good or
service to the customer as those activities occur. When licenses do not meet the criteria to be a right to access license, the license is a
“right to use” license, and the transaction price is recognized at the point in time when the customer obtains control over the license.
Sales-based or usage-based royalties
Licenses of IP can include royalties that are based on the customer’s usage of the IP or sale of products that contain the IP. The
Group apply the specific exception to the general requirements of variable consideration and the constraint on variable consideration
for sales-based or usage-based royalties promised in a license of IP. The exception requires such revenue to be recognized at the later
of when (or as) the subsequent sale or usage occurs and the performance obligation to which some or all of the sales-based or usage-
based royalty has been allocated has been satisfied (or partially satisfied).
Grünenthal arrangement
In September 2019, the Group entered into a strategic partnership with Grünenthal for the development and commercialization
in Europe and Latin America of the Group’s allogeneic mesenchymal precursor cell (“MPC”) product, MPC-06-ID, receiving
exclusive rights to the Phase 3 allogeneic product candidate for the treatment of low back pain due to degenerative disc disease.
The Group received a non-refundable upfront payment of $15.0 million in October 2019, on signing of the contract with
Grünenthal. The Group received a milestone payment in December 2019 of $2.5 million in relation to meeting a milestone event as
part of the strategic partnership with Grünenthal.
In June 2021, the Group announced its intention to leverage the results from a planned US trial to support potential product
approvals in both the US and EU by including 20% EU patients in order to provide regulatory harmonization, cost efficiencies and
streamlined timelines, without initiating an EU trial. As a result, the strategic partnership with Grünenthal has been amended and
milestone payments relating to R&D and CMC services and other development services which were linked to the Europe trial have
been removed, instead the Group is eligible to receive payments up to US$112.5 million prior to product launch in the EU, inclusive
of US$17.5 million already received, if certain clinical and regulatory milestones are satisfied and reimbursement targets are achieved.
Cumulative milestone payments could reach US$1 billion depending on the final outcome of Phase 3 studies and patient adoption. The
Group will also receive tiered double-digit royalties on product sales as per the original agreement.
The $2.5 million milestone payment received in December 2019 from Grünenthal was considered constrained and is still
considered deferred consideration as of June 30, 2021. Revenue will be recognized when the performance obligation is satisfied,
which is when the clinical trial has recruited the required amount of European patients. There was no milestone revenue recognized in
relation to this strategic partnership with Grünenthal in the year ended June 30, 2021.
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Tasly arrangement
In July 2018, the Group entered into a strategic alliance with Tasly for the development, manufacture and commercialization in
China of the Group’s allogeneic mesenchymal precursor cell MPC products, MPC-150-IM and MPC-25-IC. Tasly received all
exclusive rights for MPC-150-IM and MPC-25-IC in China and Tasly will fund all development, manufacturing and
commercialization activities in China.
The Group received a $20.0 million upfront technology access fee from Tasly upon closing of this strategic alliance in October
2018. The Group is also entitled to receive $25.0 million on product regulatory approvals in China, double-digit escalating royalties on
net product sales and up to six escalating milestone payments when the product candidates reach certain sales thresholds in China.
Under IFRS 15, upon completion of this strategic alliance in September 2018, the Group recognized $10.0 million in milestone
revenue from the $20.0 million upfront technology access fee received in October 2018, as this was the portion of revenue that control
was transferred to Tasly, and the remaining $10.0 million from the $20.0 million upfront payment was recognized as deferred
consideration on the consolidated balance sheet. In the year ended June 30, 2020, the deferred consideration amount was recognized in
revenue as the control for this portion of revenue was transferred to Tasly based on the Group’s decision regarding the exercise of the
Group’s rights in the terms and conditions of the agreement.
For the year ended June 30, 2021, no revenue was recognized in relation to this strategic alliance with Tasly.
TiGenix arrangement
In December 2017, the Group entered into a patent license agreement with TiGenix, now a wholly owned subsidiary of Takeda,
which granted Takeda exclusive access to certain of our patents to support global commercialization of the adipose-derived MSC
product, Alofisel® a registered trademark of TiGenix, previously known as Cx601, for the local treatment of fistulae. The agreement
includes the right for Takeda to grant sub-licenses to affiliates and third parties. The Group is entitled to further payments up to €10.0
million when Takeda reaches certain product regulatory milestones. Additionally, the Group will receive single digit royalties on net
sales of Alofisel®.
In the year ended June 30, 2020, the Group commenced earning royalty income on sales of Alofisel® in Europe by our licensee
Takeda. For the year ended June 30, 2021, the Group earned $0.2 million of royalty income on sales of Alofisel® in Europe by our
licensee Takeda, compared to a minimal amount year ended June 30, 2020.
JCR arrangement
In October 2013, the Group acquired all of Osiris’ culture-expanded, MSC-based assets. These assets included assumption of a
collaboration agreement with JCR, a research and development oriented pharmaceutical company in Japan. Revenue recognized under
this agreement is limited to the amount of cash received or for which the Group is entitled, as JCR has the right to terminate the
agreement at any time.
Under the JCR Agreement, JCR is responsible for all development and manufacturing costs including sales and marketing
expenses. Under the JCR Agreement the Group assumed from Osiris, JCR has the right to develop our MSCs in two fields for the
Japanese market: exclusive in conjunction with the treatment of hematological malignancies by the use of hematopoietic stem cells
derived from peripheral blood, cord blood or bone marrow, or the First JCR Field; and non-exclusive for developing assays that use
liver cells for non-clinical drug screening and evaluation, or the Second JCR Field. With respect to the First JCR Field, the Group has
received all sales milestone payments and ongoing is entitled to escalating double-digit royalties. These royalties are subject to
possible renegotiation downward in the event of competition from non-infringing products in Japan. With respect to the Second JCR
Field, the Group is entitled to a double-digit profit share. The Group expanded our partnership with JCR in Japan for two new
indications: for wound healing in patients with Epidermolysis Bullosa (“EB”) in October 2018, and for hypoxic ischemic
encephalopathy (“HIE”), a condition suffered by newborns who lack sufficient blood supply and oxygen to the brain, in June 2019.
The Group will receive royalties on TEMCELL product sales for EB and HIE, if and when JCR begins selling TEMCELL for such
indications in Japan. The Group apply the sales-based and usage-based royalty exception for licenses of intellectual property and
therefore recognize royalty revenue at the later of when the subsequent sale or usage occurs and the associated performance obligation
has been satisfied.
In the year ended, June 30, 2021 the Group recognized $7.2 million in commercialization revenue relating to royalty income
earned on sales of TEMCELL in Japan by our licensee JCR, compared with $6.6 million for the year ended June 30, 2020. These
amounts were recorded in revenue as there are no further performance obligations required in regards to these items.
197
In the year ended June 30, 2020 and 2019, the Group recognized nil million and $1.0 million, respectively, in milestone revenue
upon our licensee, JCR, reaching cumulative net sales milestones for sales of TEMCELL in Japan. This amount was recorded in
revenue as there were no further performance obligations required in regard to this item. There was no milestone revenue recognized
in year ended June 30, 2021.
(ii)
Interest revenue
Interest revenue is accrued on a time basis by reference to the principal outstanding and at the effective interest rate applicable,
which is the rate that exactly discounts estimated future cash receipts through the expected life of the financial asset to that asset’s net
carrying amount.
(iii) Research and development tax incentive
The Australian Government replaced the research and development tax concession with the research and development tax
incentive from July 1, 2011. The provisions provide refundable or non-refundable tax offsets.
The research and development tax incentive applies to expenditure incurred and the use of depreciating assets in an income year
commencing on or after July 1, 2011. The research and development tax incentive credit is available for our research and development
activities in Australia as well as research and development activities outside of Australia to the extent such non-Australian based
activities relate to intellectual property owned by our Australian resident entities do not exceed half the expenses for the relevant
activities and are approved by the Australian government. A refundable tax offset is available to eligible companies with an annual
aggregate turnover of less than A$20.0 million. Eligible companies can receive a refundable tax offset for a percentage of their
research and development spending. For the years ended June 30, 2021 and 2020, the rate of the refundable tax offset is 43.5%.
The combined worldwide turnover of the Mesoblast Group did not exceed of A$20.0 million for the year ended June 30, 2021
making us eligible for the refundable tax offset for the research and development tax incentive. However, management determined the
majority of activities were not eligible under the incentive scheme and therefore did not apply for a tax offset. The Group was
ineligible for the refundable tax offset for the research and development tax incentive for the year ended June 30, 2020. Consequently,
no income was recognized from the Research and Development Tax Incentive program for the year ended June 30, 2021 and 2020.
The Group’s research and development activities can potentially be eligible under an Australian government tax incentive.
Management has assessed these activities and expenditure to determine which are likely to be eligible under the incentive scheme. At
each period end management estimates and recognizes the refundable tax offset available to the Group based on available information
at the time.
The receivable for reimbursable amounts that have not been collected is reflected in trade and other receivables in the Group’s
consolidated balance sheets. Income associated with the research and development tax incentive is recorded in the Group’s other
operating income and expenses in the Group’s consolidated income statement.
f.
Inventories
Inventories are included in the financial statements at the lower of cost (including raw materials, direct labour, other direct costs
and related production overheads) and net realizable value. Pre-launch inventory is held as an asset when there is a high probability of
regulatory approval for the product in accordance with IAS 2 Inventories. Before that point, a provision is made against the carrying
value to its recoverable amount in accordance with IAS 37 Provisions, Contingent Liabilities and Contingent Assets; the provision is
then reversed at the point when a high probability of regulatory approval is determined.
The Group considers a number of factors in determining the probability of the product candidate realizing future economic
benefit, including the product candidate’s current status in the regulatory approval process, results from the related pivotal clinical
trial, results from meetings with relevant regulatory agencies prior to the filing of regulatory applications, the market need, historical
experience, as well as potential impediments to the approval process such as product safety or efficacy, commercialization and market
trends.
When a provision is made against the carrying value of pre-launch inventory the costs are recognized within Manufacturing
Commercialization expenses. When the high probability threshold is met, the provision will be reversed through Manufacturing
Commercialization expenses. As of June 30, 2021 and June 30, 2020, there was $21.9 million and $8.8 million of pre-launch
inventory recognized on the balance sheet that was fully provided for, respectively. For the year ended June 30, 2021 and the year
ended June 30, 2020 $13.1 million and $8.8 million of pre-launch inventory costs have been recognized within Manufacturing
Commercialization expenses in relation to the provision against the carrying value of pre-launch inventory. For the year ended June
198
30, 2021, $0.5 million of pre-launch inventory costs were provided for as obsolete stock and these costs have been recognized within
Manufacturing Commercialization expenses during the period. There was no provision for obsolete stock at June 30, 2020.
g.
Research and development undertaken internally
The Group currently does not have any capitalized development costs. Research expenditure is recognized as an expense as
incurred. Costs incurred on development projects, which consist of preclinical and clinical trials, manufacturing development, and
general research, are recognized as intangible assets when it is probable that the project will, after considering its commercial and
technical feasibility, be completed and generate future economic benefits and its costs can be measured reliably.
The expenditure capitalized comprises all directly attributable costs, including costs of materials, services, direct labor and an
appropriate proportion of overheads. Other development costs that do not meet these criteria are expensed as incurred. Development
costs previously recognized as expenses, are not recognized as an asset in a subsequent period and will remain expensed. Capitalized
development costs are recorded as intangible assets and amortized from the point at which the asset is ready for use on a straight-line
basis over its useful life.
h.
Income tax
The income tax expense or benefit for the period is the tax payable on the current period’s taxable income based on the
applicable income tax rate for each jurisdiction adjusted by changes in deferred tax assets and liabilities attributable to temporary
differences and to unused tax losses.
The current income tax charge is calculated on the basis of the tax laws enacted or substantively enacted at the end of the
reporting period in the countries where the Group’s subsidiaries and associates operate and generate taxable income. Management
periodically evaluates positions taken in tax returns with respect to situations in which applicable tax regulation is subject to
interpretation. It establishes provisions where appropriate on the basis of amounts expected to be paid to the tax authorities.
Deferred income tax is provided in full, using the liability method, on temporary differences arising between the tax bases of
assets and liabilities and their carrying amounts in the consolidated financial statements. However, the deferred income tax is not
accounted for if it arises from initial recognition of an asset or liability in a transaction other than a business combination that at the
time of the transaction affects neither accounting, nor taxable profit or loss. Deferred income tax is determined using tax rates (and
laws) that have been enacted or substantially enacted by the end of the reporting period and are expected to apply when the related
deferred income tax asset is realized or the deferred income tax liability is settled.
Deferred tax assets are recognized for deductible temporary differences and unused tax losses only if it is probable that future
taxable amounts will be available to utilize those temporary differences and losses. Deferred tax assets are only recognized to the
extent that there are sufficient deferred tax liabilities unwinding.
Deferred tax liabilities and assets are not recognized for temporary differences between the carrying amount and tax bases of
investments in controlled entities where the parent entity is able to control the timing of the reversal of the temporary differences and
it is probable that the differences will not reverse in the foreseeable future.
Deferred tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets and liabilities
and when the deferred tax balances relate to the same taxation authority. Current tax assets and tax liabilities are offset where the
entity has a legally enforceable right to offset and intends either to settle on a net basis, or to realize the asset and settle the liability
simultaneously.
Current and deferred tax is recognized in net loss, except to the extent that it relates to items recognized in other comprehensive
income or directly in equity. In this case, the tax is also recognized in other comprehensive income or directly in equity, respectively.
i.
Business combinations
The acquisition method of accounting is used to account for all business combinations, regardless of whether equity instruments
or other assets are acquired. The consideration transferred for the acquisition of a subsidiary comprises the fair values of the assets
transferred, the liabilities incurred and the equity interests issued by the Group. The consideration transferred also includes the fair
value of any asset or liability resulting from a contingent consideration arrangement and the fair value of any pre-existing equity
interest in the subsidiary. Acquisition-related costs are expensed as incurred. Identifiable assets acquired and liabilities and contingent
liabilities assumed in a business combination are, with limited exceptions, measured initially at their fair values at the acquisition date.
On an acquisition-by-acquisition basis, the Group recognizes any noncontrolling interest in the acquiree either at fair value or at the
non-controlling interest’s proportionate share of the acquiree’s net identifiable assets.
199
The excess of the consideration transferred and the amount of any non-controlling interest in the acquiree over the fair value of
the net identifiable assets acquired is recorded as goodwill. If those amounts are less than the fair value of the net identifiable assets of
the subsidiary acquired and the measurement of all amounts has been reviewed, the difference is recognized directly in net loss as a
bargain purchase.
Where settlement of any part of cash consideration is deferred, the amounts payable in the future are discounted to their present
value as at the date of exchange. The discount rate used is the entity’s incremental borrowing rate, being the rate at which a similar
borrowing could be obtained from an independent financier under comparable terms and conditions.
Contingent consideration is classified either as equity or a financial liability. Amounts classified as a financial liability are
subsequently remeasured to fair value with changes in fair value recognized in profit or loss.
j.
Impairment of assets
Goodwill and intangible assets that have an indefinite useful life are not subject to amortization and are tested annually for
impairment or more frequently if events or changes in circumstances indicate that they might be impaired. Other assets are tested for
impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.
An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The
recoverable amount is the higher of an asset’s fair value less costs to dispose and value in use. For the purposes of assessing
impairment, assets are grouped at the lowest levels for which there are separately identifiable cash inflows which are largely
independent of the cash inflows from other assets or groups of assets (cash-generating units). Non-financial assets (other than
goodwill) that have suffered impairment are reviewed for possible reversal of the impairment at the end of each reporting period.
Management maintains internal valuations of each asset annually (or more frequently should indicators of impairment be
identified) and valuations from independent experts are requested periodically, within every three year period. The internal valuations
are continually reviewed by management and consideration is given as to whether there are indicators of impairment which would
warrant impairment testing. An external valuation of our assets was carried out by an independent expert as at March 31, 2020 with
the recoverable amount of each asset exceeding its carrying amount.
k.
Cash and cash equivalents
For the purpose of presentation in the statement of cash flows, cash and cash equivalents includes cash on hand, deposits held at
call with financial institutions, other short-term and highly liquid investments with original maturities of three months or less that are
readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in value.
l.
Trade and other receivables
Trade receivables and other receivables represent the principal amounts due at balance date less, where applicable, any
provision for expected credit losses. The Group uses the simplified approach to measuring expected credit losses, which uses a
lifetime expected credit loss allowance. Debts which are known to be uncollectible are written off in the consolidated income
statement. All trade receivables and other receivables are recognized at the value of the amounts receivable, as they are due for
settlement within 60 days and therefore do not require remeasurement.
m.
(i)
Investments and other financial assets
Classification
The Group classifies its financial assets in the following measurement categories:
•
•
those to be measured subsequently at fair value (either through OCI or through profit or loss); and
those to be measured at amortized cost
The classification depends on the Group’s business model for managing the financial assets and the contractual terms of the
cash flow. For assets measured at fair value, gains and losses will either be recorded in profit or loss or OCI. For investments in equity
instruments that are not held for trading, this will depend on whether the group has made an irrevocable election at the time of initial
recognition to account for the equity investment at fair value through other comprehensive income (FVOCI). See Note 5 for details
about each type of financial asset.
200
(ii) Recognition and derecognition
Regular way purchases and sales of financial assets are recognized on trade-date, the date on which the Group commits to
purchase or sell the asset. Financial assets are derecognized when the rights to receive cash flows from the financial assets have
expired or have been transferred and the Group has transferred substantially all the risks and rewards of ownership.
(iii) Measurement
At initial recognition, the Group measures a financial asset at its fair value plus, in the case of a financial asset not at fair value
through profit or loss (FVPL), transaction costs that are directly attributable to the acquisition of the financial asset. Transaction costs
of financial assets carried at FVPL are expensed in profit or loss. Financial assets with embedded derivatives are considered in their
entirety when determining whether their cash flows are solely payment of principal and interest.
Details on how the fair value of financial instruments is determined are disclosed in Note 5(g).
Equity instruments
The group subsequently measures all equity investments at fair value. Where the Group has elected to present fair value gains
and losses on equity investments in OCI, there is no subsequent reclassification of fair value gains and losses to profit or loss
following the derecognition of the investment. Dividends from such investments continue to be recognized in profit or loss as other
income when the group’s right to receive payments is established.
Changes in the fair value of financial assets at FVPL are recognized in other gains/(losses) in the statement of profit or loss as
applicable. Impairment losses (and reversal of impairment losses) on equity investments measured at FVOCI are not reported
separately from other changes in fair value.
(iv)
Impairment
For trade receivables, the group applies the simplified approach permitted by IFRS 9, which requires expected lifetime losses to
be recognized from initial recognition of the receivables, see Note 5(b) for further details.
n.
Derivatives
Derivatives are initially recognized at fair value on the date a derivative contract is entered into and are subsequently
remeasured to their fair value at the end of each reporting period.
Derivatives that do not qualify for hedge accounting
Certain derivative instruments do not qualify for hedge accounting. Changes in the fair value of any derivative instrument that
does not qualify for hedge accounting are recognized immediately in profit or loss and are included in other income or other expenses.
o.
Property, plant and equipment
Plant and equipment are stated at historical cost less accumulated depreciation and impairment. Cost includes expenditure that is
directly attributable to the acquisition of the item.
Subsequent cost are included in the asset’s carrying amount or recognized as a separate asset, as appropriate, only when it is
probable that future economic benefits associates with the item will flow to the Group and the cost of the item can be measured
reliably. All other repairs and maintenance are charged to profit and loss during the reporting period in which they are incurred.
Property, plant and equipment, other than freehold land, are depreciated over their estimated useful lives using the straight line
method (see Note 6(a)).
The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at the end of each reporting period.
An asset’s carrying amount is written down immediately to its recoverable amount if the asset’s carrying amount is greater than
its estimated recoverable amount.
Gains and losses on disposal of plant and equipment are taken into account in determining the profit for the year.
201
p.
(i)
Intangible assets
Goodwill
Goodwill is measured as described in Note 23(i). Goodwill on acquisition of subsidiaries is included in intangible assets (Note
6(c)). Goodwill is not amortized but it is tested for impairment annually or more frequently if events or changes in circumstances
indicate that it might be impaired, and is carried at cost less accumulated impairment losses. Gains and losses on the disposal of an
entity include the carrying amount of goodwill relating to the entity sold.
Goodwill is tested for impairment in accordance with IAS 36 Impairment of Assets which requires testing be performed at any
time during an annual period, provided the test is performed at the same time every year. The Group tests for impairment annually in
the third quarter of each year. Additionally, assets must be tested for impairment if there is an indication that an asset may be
impaired. The recoverable amounts of our assets and cash-generating units have been determined based on fair value less costs to sell
calculations, which require the use of certain assumptions.
Goodwill is allocated to cash generating units for the purpose of impairment testing. The allocation is made to those cash
generating units or groups of cash generating units that are expected to benefit from the business combination in which the goodwill
arose, identified according to operating segments (Note 21).
(ii) Acquired licenses to patents
Acquired licenses have a finite useful life and are carried at cost less accumulated amortization and impairment losses. Each
asset is amortized through to the estimated patent expiry date which is reviewed and adjusted as patent extensions are granted.
Payments made to third parties to acquire licenses to patents, including initial upfront and subsequent milestone payments are
capitalized. For subsequent payments under existing license agreements payments are capitalized if they meet the definition of an
intangible asset. Management reviews the substance of the payment to determine its classification. Generally, payments made for a
verifiable outcome, such as completion of a clinical trial, regulatory approvals and sales target milestones would be accumulated into
the cost of the intangible.
The Group periodically evaluates whether current facts or circumstances indicate that the carrying value of its acquired
intangibles may not be recoverable. If such circumstances are determined to exist, an estimate of the undiscounted future cash flow of
these assets, or appropriate assets grouping is compared to the carrying value to determine whether an impairment exists. If the asset is
determined to be impaired, the loss is measured based on the differences between the carrying value of the intangible asset and its fair
value, which is determined based on the net present value of estimated future cash flows.
Royalty payments under license and sublicense agreements are expensed.
(iii)
In-process research and development acquired
In-process research and development that has been acquired as part of a business acquisition is considered to be an indefinite life
intangible asset on the basis that it is incomplete and cannot be used in its current form. Indefinite life intangible assets are not
amortized but rather are tested for impairment annually in the third quarter of each year, or whenever events or circumstances present
an indication of impairment.
In-process research and development will continue to be tested for impairment until the related research and development efforts
are either completed or abandoned. Upon completion of the related research and development efforts, management determines the
remaining useful life of the intangible assets and amortizes them accordingly. In order for management to determine the remaining
useful life of the asset, management would consider the expected flow of future economic benefits to the entity with reference to the
product life cycle, competitive landscape, obsolescence, market demand, any remaining patent useful life and various other relevant
factors. At the time of completion, when the asset becomes available for use, all costs recognized in in-process research and
development that related to the completed asset are transferred to the intangible asset category, current marketed products, at the
asset’s historical cost.
In the case of abandonment, the related research and development efforts are considered impaired and the asset is fully
expensed.
(iv) Current marketed products
Current marketed products contain products that are currently being marketed. The assets are recognized on our balance sheet as
a result of business acquisitions or reclassifications from In-process research and development upon completion. Upon completion,
202
when assets become available for use, assets are reclassified from in-process research and development to current marketed products
at the historical value that they were recognized at within the in-process research and development category.
Upon reclassification to the current market products category management determines the remaining useful life of the intangible
assets and amortizes them from the date they become available for use. In order for management to determine the remaining useful life
of the asset, management would consider the expected flow of future economic benefits to the entity with reference to the product life
cycle, competitive landscape, obsolescence, market demand, any remaining patent useful life and any other relevant factors.
Management have chosen to amortize all intangible assets with a finite useful life on a straight-line basis over the useful life of
the asset. Current marketed products are tested for impairment in accordance with IAS 36 Impairment of Assets which requires testing
whenever there is an indication that an asset may be impaired.
q.
Trade and other payables
Payables represent the principal amounts outstanding at balance date plus, where applicable, any accrued interest. Liabilities for
payables and other amounts are carried at cost which approximates fair value of the consideration to be paid in the future for goods
and services received, whether or not billed. The amounts are unsecured and are usually paid within 30 to 60 days of recognition.
r.
Borrowings
Borrowings are initially recognized at fair value, net of transaction costs incurred. Borrowings are subsequently measured at
amortized cost. Any difference between the proceeds (net of transaction costs) and the redemption amount is recognized in profit or
loss over the period of the borrowings using the effective interest method. Fees paid on the establishment of loan facilities are
recognized as transaction costs of the loan to the extent that it is probable that some or all of the facility will be drawn down. If it is
not probable, the fee is deferred until the draw down occurs. To the extent there is no evidence that it is probable that some or all of
the facility will be drawn down, the fee is capitalized as a prepayment for liquidity services and amortized over the period of the
facility to which it relates.
Borrowings are removed from the balance sheet when the obligation specified in the contract is discharged, cancelled or
expired. The difference between the carrying amount of a financial liability that has been extinguished or transferred to another party
and the consideration paid, including any non-cash assets transferred of liabilities assumed, is recognized in profit or loss as other
income or finance costs.
Borrowings are classified as current liabilities unless the Group has an unconditional right to defer settlement of the liability for
at least 12 months after the reporting period
Hercules
In March 2018, the Group entered into a loan and security agreement with Hercules, for a $75.0 million non-dilutive, four-year
credit facility. The Group drew the first tranche of $35.0 million on closing and a further tranche of $15.0 million was drawn in
January 2019. The loan matures in March 2022.
In May 2021, the Group and Hercules amended the terms of the loan and security agreement to extend the interest-only period
to October 1, 2021. In August 2021, the Group and Hercules amended the terms of the loan and security agreement to extend the
interest-only period to January 1, 2022. Principal repayments can be further deferred to March 2022, subject to achieving certain
milestones.
Interest on the loan is payable monthly in arrears on the 1st day of the month. At closing date, the interest rate was 9.45%. At
June 30, 2019, in line with increases in the U.S prime rate, the interest rate was 10.45%. On August 1, September 19 and October 31,
2019, in line with the decreases in the U.S. prime rate, the interest rate on the loan decreased to 10.20%, 9.95% and 9.70%,
respectively, and remains at 9.70% at June 30, 2021, in line with the terms of the loan agreement. As at June 30, 2021, the Group
recognized $2.2 million in interest payable within twelve months as a current liability.
In the years ended June 30, 2021 and 2020, the Group recognized gains of $0.4 million and $1.3 million, respectively, in the
Income Statement as remeasurement of borrowing arrangements within finance costs. These remeasurement gains relate to the
adjustment of the carrying amount of our financial liability to reflect the revised estimated future cash flows from our existing credit
facility.
203
NovaQuest
On June 29, 2018, the Group drew the first tranche of $30.0 million of the principal amount from the $40.0 million loan and
security agreement with NovaQuest. There is a four-year interest only period, until July 2022, with the principal repayable in equal
quarterly instalments over the remaining period of the loan. The loan matures in July 2026. Interest on the loan will accrue at a fixed
rate of 15% per annum.
All interest and principal payments will be deferred until after the first commercial sale of remestemcel-L for the treatment in
pediatric patients with SR-aGVHD. The Group can elect to prepay all outstanding amounts owing at any time prior to maturity,
subject to a prepayment charge, and may decide to do so if net sales of remestemcel-L for pediatric SR-aGVHD are significantly
higher than current forecasts.
If there are no net sales of remestemcel-L for pediatric SR-aGVHD, the loan is only repayable on maturity in 2026. If in any
annual period 25% of net sales of remestemcel-L for pediatric SR-aGVHD exceed the amount of accrued interest owing and, from
2022, principal and accrued interest owing (“the payment cap”), Mesoblast will pay the payment cap and an additional portion of
excess sales which may be used for early prepayment of the loan. If in any annual period 25% of net sales of remestemcel-L for
pediatric SR-aGVHD is less than the payment cap, then the payment is limited to 25% of net sales of remestemcel-L for pediatric SR-
aGVHD. Any unpaid interest will be added to the principal amounts owing and shall accrue further interest. At maturity date, any
unpaid loan balances are repaid.
Because of this relationship of net sales and repayments, changes in our estimated net sales may trigger an adjustment of the
carrying amount of the financial liability to reflect the revised estimated cash flows. The carrying amount adjustment is recalculated
by computing the present value of the revised estimated future cash flows at the financial instrument’s original effective interest rate.
The adjustment is recognized in the Income Statement as remeasurement of borrowing arrangements within finance costs in the period
the revision is made.
In the year ended June 30, 2021, the Group recognized a gain of $4.8 million in the Income Statement as remeasurement of
borrowing arrangements within finance costs in relation to the adjustment of the carrying amount of our financial liability to reflect the
revised estimated future cash flows as a net result of changes to the key assumptions in development timelines. In the year ended June
30, 2020 the Group recognized a loss of $0.7 million in the Income Statement as remeasurement of borrowing arrangements within
finance costs in relation to the adjustment of the carrying amount of our financial liability to reflect the revised estimated future cash
flows.
As at June 30, 2021, the Group has recognized a current liability of $0.3 million which represents the present value of $0.4
million loan administration fee which is payable annually in June.
The carrying amount of the loan and security agreement with NovaQuest is subordinated to the Group’s floating rate loan with
the senior creditor, Hercules.
s.
Provisions
Provisions are recognized when the Group has a present legal obligation as a result of a past event, it is probable that the Group
will be required to settle the obligation, and a reliable estimate can be made of the amount of the obligation.
Provisions are measured at the present value of management’s best estimate of the expenditure required to settle the present
obligation at the end of the reporting period. The discount rate used to determine the present value is a pre-tax rate that reflects current
market assessments of the time value of money and the risks specific to the liability. The increase in the provision due to the passage
of time is recognized as interest expense.
Provisions are recorded on acquisition of a subsidiary, to the extent they relate to a subsidiary’s contingent liabilities, if it relates
to a past event, regardless of whether it is probable the amount will be paid.
t.
Employee benefits
A liability is recognized for benefits accruing to employees in respect of wages and salaries, bonuses, annual leave and long
service leave.
Liabilities recognized in respect of employee benefits which are expected to be settled within 12 months after the end of the
period in which the employees render the related services are measured at their nominal values using the remuneration rates expected
to apply at the time of settlement.
204
Liabilities recognized in respect of employee benefits which are not expected to be settled within 12 months after the end of the
period in which the employees render the related services are measured as the present value of the estimated future cash outflows to be
made by the Group in respect of services provided by employees up to reporting date.
The obligations are presented as current liabilities in the balance sheet if the entity does not have an unconditional right to defer
settlement for at least twelve months after the reporting period, regardless of when the actual settlement is expected to occur.
Termination benefits are payable when employment is terminated by the Group before the normal retirement date, or when an
employee accepts voluntary redundancy in exchange for these benefits. The Group recognizes termination benefits at the earlier of the
following dates: when the Group can no longer withdraw the offer of those benefits and when the entity recognizes costs for a
restructuring that is within the scope of IAS 37 and involves the payment of termination benefits.
u.
Share-based payments
Share-based payments are provided to eligible employees, directors and consultants via the Employee Share Option Plan
(“ESOP”) and the Australian Loan Funded Share Plan (“LFSP”). The terms and conditions of the LFSP are in substance the same as
the employee share options and therefore they are accounted for on the same basis.
Equity-settled share-based payments with employees and others providing similar services are measured at the fair value of the
equity instrument at acceptance date. Fair value is measured using the Black-Scholes model. The expected life used in the model has
been adjusted, based on management’s best estimate, for the effects of non-transferability, exercise restrictions, and behavioral
considerations. It does not make any allowance for the impact of any service and non-market performance vesting conditions. Further
details on how the fair value of equity-settled share-based transactions has been determined can be found in Note 17.
The fair value determined at the acceptance date of the equity-settled share-based payments is expensed on a straight-line basis
over the vesting period, based on management’s estimate of shares that will eventually vest, with a corresponding increase in equity.
At the end of each period, the entity revises its estimates of the number of shared-based payments that are expected to vest based on
the non-market vesting conditions. It recognizes the impact of the revision to original estimates, if any, in profit or loss, with a
corresponding adjustment to equity.
v.
Leases
Leases are recognized as a right-of-use asset and a corresponding liability at the date at which the leased asset is available for
use by the Group. Assets and liabilities arising from a lease are initially measured on a present value basis. Lease liabilities include the
net present value of the following lease payments:
•
•
•
•
•
fixed payments (including in-substance fixed payments), less any lease incentives receivable;
variable lease payment that are based on an index or a rate;
amounts expected to be payable by the lessee under residual value guarantees;
the exercise price of a purchase option if the lessee is reasonably certain to exercise that option; and
payments of penalties for terminating the lease, if the lease term reflects the lessee exercising that option.
Variable lease payments that are not based on an index or a rate are not included in the initial measurement of the lease liability
and are expensed in the Income Statement when incurred. There were no variable lease payments that were expensed in the Income
Statement for the year ended June 30, 2021. The Group remeasures the lease liability and makes a corresponding adjustment to the
related right-of-use asset whenever there is a change to the lease terms or expected payments under the lease, or a modification that is
not accounted for as a separate lease.
For certain contracts that contain lease and non-lease components, the Group accounts for each lease component within the
contract as a lease separately from non-lease components of the contract. The Group identifies a separate lease component if there is
an explicit or implicit identified asset in the contract and if the Group controls use of the identified asset.
The lease payments are discounted using the interest rate implicit in the lease, if that rate can be determined, or the Group’s
incremental borrowing rate.
Right-of-use assets are measured at cost comprising the following:
•
the amount of the initial measurement of lease liability;
205
•
•
•
any lease payments made at or before the commencement date, less any lease incentives received;
any initial direct costs; and
restoration costs.
Payments associated with short-term leases with a lease term of 12 months or less, contracts that contain lease and non-lease
components that are cancellable within 12 months and leases of low-value assets are recognized on a straight-line basis as an expense
in profit or loss. Low-value assets comprise IT-equipment and small items of office furniture.
w.
Contributed equity
Ordinary shares are classified as equity.
Transaction costs arising on the issue of equity instruments are recognized separately in equity. Transaction costs are the costs
that are incurred directly in connection with the issue of those equity instruments and which would not have been incurred had those
instruments not been issued.
x.
(i)
Loss per share
Basic losses per share
Basic losses per share is calculated by dividing:
•
•
the loss attributable to equity holders of the Group, excluding any costs of servicing equity other than ordinary shares;
by the weighted average number of ordinary shares outstanding during the fiscal year, adjusted for bonus elements in
ordinary shares issued during the year.
(ii) Diluted losses per share
Diluted losses per share adjusts the figures used in the determination of basic earnings per share to take into account
•
•
the after income tax effect of interest and other financing costs associated with dilutive potential ordinary shares; and
the weighted average number of shares assumed to have been issued for no consideration in relation to dilutive potential
ordinary shares.
y.
Goods and services tax (“GST”)
Revenues, expenses and assets are recognized net of the amount of GST except where the GST incurred on a purchase of goods
and services is not recoverable from the taxation authority, in which case the GST is recognized as part of the cost of acquisition of the
asset or as part of the expense.
Receivables and payables are stated with the amount of GST included. The net amount of GST recoverable from, or payable to,
the taxation authority is included as part of receivables or payables in the Balance Sheet.
Cash flows are included in the statement of cash flow on a gross basis. The GST component of cash flows arising from investing
and financing activities, which is recoverable from, or payable to, the taxation authority, are classified as operating cash flows.
z.
Rounding of amounts
Our company is of a kind referred to in ASIC Corporations (Rounding in Financial/Directors’ Reports) Instrument 2016/191,
issued by the Australian Securities and Investments Commission, relating to the ‘rounding off’ of amounts in the financial report.
Unless mentioned otherwise, amounts within this report have been rounded off in accordance with that Legislative Instrument to the
nearest thousand dollars, or in certain cases, to the nearest dollar.
206
Australian Disclosure Requirements
Directors’ Declaration
In the directors’ opinion:
(a)
the financial statements and Notes set out on pages 140 to 206 are in accordance with the Corporations Act 2001,
including:
(i)
Complying with Accounting Standards, the Corporations Regulations 2001 and other mandatory professional
reporting requirements, and
(ii) Giving a true and fair view of the consolidated entity’s financial position as at June 30, 2021 and of its performance
for the fiscal year ended on that date, and
(b)
There are reasonable grounds to believe that the Group will be able to pay its debts as and when they become due and
payable.
Note 1 ‘Basis of preparation’ confirms that the financial statements also comply with International Financial Reporting
Standards as issued by the International Accounting Standards Board.
The directors have been given the declarations by the chief executive officer and chief financial officer required by section
295A of the Corporations Act 2001.
This declaration is made in accordance with a resolution of the directors.
/s/ Joseph Swedish
Joseph Swedish
Chairman
Melbourne, August 31, 2021
/s/ Silviu Itescu
Silviu Itescu
Chief Executive Officer
207
Independent auditor’s report
To the members of Mesoblast Limited
Report on the audit of the financial report
Our opinion
In our opinion:
The accompanying financial report of Mesoblast Limited (the Company) and its controlled entities
(together the Group) is in accordance with the Corporations Act 2001, including:
(a) giving a true and fair view of the Group's financial position as at 30 June 2021 and of its
financial performance for the year then ended
(b) complying with Australian Accounting Standards and the Corporations Regulations 2001.
What we have audited
The Group financial report comprises:
•
•
•
•
•
•
•
the consolidated balance sheet as at 30 June 2021
the consolidated income statement for the year then ended
the consolidated statement of comprehensive income for the year then ended
the consolidated statement of changes in equity for the year then ended
the consolidated statement of cash flows for the year then ended
the notes to consolidated financial statements, which include significant accounting policies and
other explanatory information
the directors’ declaration.
Basis for opinion
We conducted our audit in accordance with Australian Auditing Standards. Our responsibilities under
those standards are further described in the Auditor’s responsibilities for the audit of the financial
report section of our report.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for
our opinion.
Independence
We are independent of the Group in accordance with the auditor independence requirements of the
Corporations Act 2001 and the ethical requirements of the Accounting Professional & Ethical
Standards Board’s APES 110 Code of Ethics for Professional Accountants (including Independence
Standards) (the Code) that are relevant to our audit of the financial report in Australia. We have also
fulfilled our other ethical responsibilities in accordance with the Code.
PricewaterhouseCoopers, ABN 52 780 433 757
2 Riverside Quay, SOUTHBANK VIC 3006, GPO Box 1331 MELBOURNE VIC 3001
T: +61 3 8603 1000, F: +61 3 8603 1999, www.pwc.com.au
Liability limited by a scheme approved under Professional Standards Legislation.
208
Material uncertainty related to going concern
We draw attention to Note 1(i) in the financial report, which indicates over the next twelve months in
order to meet forecast expenditure, including repayment of the Hercules debt facility, cash inflows will
be required. The ability of the Group to continue as a going concern is dependent on completing either
one or more strategic partnerships or restructuring existing loan agreements. The dependency on
these planned events indicate that a material uncertainty exists that may cast significant doubt on the
Group’s ability to continue as a going concern. Our opinion is not modified in respect of this matter.
Our audit approach
An audit is designed to provide reasonable assurance about whether the financial report is free from
material misstatement. Misstatements may arise due to fraud or error. They are considered material if
individually or in aggregate, they could reasonably be expected to influence the economic decisions of
users taken on the basis of the financial report.
We tailored the scope of our audit to ensure that we performed enough work to be able to give an
opinion on the financial report as a whole, taking into account the geographic and management
structure of the Group, its accounting processes and controls and the industry in which it operates.
The Group is a biopharmaceutical entity headquartered in Melbourne, Australia. It is in the process of
developing and commercialising innovative cell-based medicines for inflammatory diseases. The
Group has operations in Australia, the United States and Singapore. It is headquartered in Melbourne,
Australia.
Materiality
Audit scope
•
For the purpose of our audit we used overall
Group materiality of $5.9 million, which
represents approximately 5% of the Group’s
adjusted loss before income tax.
• We applied this threshold, together with
qualitative considerations, to determine the scope
of our audit and the nature, timing and extent of
our audit procedures and to evaluate the effect of
misstatements on the financial report as a whole.
•
•
Our audit focused on where the Group made
subjective judgements; for example, significant
accounting estimates involving assumptions and
inherently uncertain future events.
Audit procedures were performed over
Australian, United States and Singaporean
operations to enable us to give an opinion over
the financial report as a whole. Under instruction
and supervision by PwC Australia, local
209
component auditors in the United States assisted
with the procedures.
• We chose Group adjusted loss before income tax
because, in our view, it is the benchmark against
which the performance of the Group is most
commonly measured. We adjusted for the fair
value remeasurement of contingent consideration
as it fluctuates from year to year.
• We utilised a 5% threshold based on our
professional judgement, noting it is within the
range of commonly acceptable thresholds.
Key audit matters
Key audit matters are those matters that, in our professional judgement, were of most significance in
our audit of the financial report for the current period. The key audit matters were addressed in the
context of our audit of the financial report as a whole, and in forming our opinion thereon, and we do
not provide a separate opinion on these matters. Further, any commentary on the outcomes of a
particular audit procedure is made in that context. We communicated the key audit matters to the
Audit and Risk Committee.
In addition to the matter described in the Material uncertainty related to going concern section, we
have determined the matters described below to be the key audit matters to be communicated in our
report.
Key audit matter
How our audit addressed the key audit
matter
Impairment assessment of in-process
research and development intangible assets
and goodwill
As described in Note 6(c) to the consolidated financial
statements, the Group’s consolidated in-process
research and development (“IPRD”) intangible asset
balance and consolidated goodwill balance were
$427.8 million and $134.5 million at 30 June 2021,
respectively.
The Group tests the IPRD intangible asset and
goodwill balances for impairment on an annual basis.
The recoverability of the carrying values of goodwill
and IPRD intangible assets are estimated by the
Group using future cash flow projections and
assumptions related to the outcome of research and
development activities. These significant judgements
and assumptions made by the Group are specific to
the nature of the Group’s activities including
estimates of market populations, product pricings,
Our audit procedures included, among others, testing
the Group’s process used to develop the fair value
estimate, which included:
•
•
•
evaluating the appropriateness of the
valuation methodology and discounted cash
flow models used to estimate recoverable
amount of the Group’s IPRD and goodwill;
testing the completeness, accuracy and
relevance of the underlying data used in the
models; and
evaluating the appropriateness of significant
assumptions used by the Group including,
including estimates of market populations,
product pricings, launch timings,
probabilities of success and discount rates.
210
Key audit matter
How our audit addressed the key audit
matter
launch timings, probabilities of success and discount
rates.
The principal considerations for our determination
that performing procedures relating to the
impairment assessment of IPRD intangible assets and
goodwill is a key audit matter are there were
significant judgements made by the Group in
estimating the recoverable amount of the Group’s
IPRD and goodwill. This in turn led to a high degree
of auditor judgement, subjectivity, and effort in
performing procedures to evaluate the Group’s cash
flow projections and significant assumptions,
including estimates of market populations, product
pricings, launch timings, probabilities of success and
discount rates. In addition, the audit effort involved
the use of professionals with specialised skill and
knowledge to assist in performing these procedures
and evaluating the audit evidence obtained.
Fair value measurement of the provision for
contingent consideration
Evaluating the significant assumptions relating to
the estimates of the recoverable amount of IPRD
assets and goodwill involved evaluating whether
the assumptions used by the Group were
appropriate considering consistency with:
•
•
•
•
external market and industry data;
the outcome of clinical trials;
announcements made by the Group; and
other comparable estimates of the
Group’s valuation released by securities
analysts.
Professionals with specialised skill and
knowledge were used to assist in the evaluation of
the Group’s discount rate assumption.
As described in Note 5(g) to the consolidated financial
statements, the Group had a balance of $25.4 million
as at 30 June 2021, for the provision for contingent
consideration, which the Group determined using an
internal valuation requiring the use of inputs
classified as level 3 in the fair value hierarchy. The
provision for contingent consideration is determined
using a discounted cash flow model. Significant
assumptions used by the Group to value the provision
for contingent consideration included probabilities of
success.
The principal considerations for our determination
that performing procedures relating to the fair value
measurement of contingent consideration is a key
audit matter are there were significant judgements
made by the Group in estimating the fair value of the
provision for contingent consideration. This in turn
led to high degree of auditor judgement, subjectivity,
and effort in performing procedures to evaluate the
Our audit procedures included, among others, testing
the Group’s process used to develop the fair value
estimate, which included:
•
•
•
evaluating the appropriateness of the
valuation methodology and discounted cash
flow model used to estimate the value of the
provision;
testing the completeness, accuracy and
relevance of the underlying data used in the
model;
evaluating the appropriateness of significant
assumptions used by the Group including,
including probabilities of success.
Evaluating the significant assumptions relating to the
fair value measurement of the provision for
contingent consideration involved evaluating whether
the assumptions used by the Group were appropriate
considering consistency with:
211
Key audit matter
How our audit addressed the key audit
matter
Group’s cash flow projections and significant
assumptions, including probabilities of success.
•
•
•
•
external market and industry data;
the outcome of clinical trials;
announcements made by the Group; and
evidence obtained from our procedures over
the impairment assessment of IPRD
intangible assets and goodwill.
Other information
The directors are responsible for the other information. The other information comprises the
information included in the annual report for the year ended 30 June 2021, but does not include the
financial report and our auditor’s report thereon. Prior to the date of this auditor's report, the other
information we obtained included the Part I, Part II and Items 17 and 19 of Part III of the Form 20-F.
We expect the remaining other information to be made available to us after the date of this auditor's
report.
Our opinion on the financial report does not cover the other information and we do not and will not
express an opinion or any form of assurance conclusion thereon.
In connection with our audit of the financial report, our responsibility is to read the other information
and, in doing so, consider whether the other information is materially inconsistent with the financial
report or our knowledge obtained in the audit, or otherwise appears to be materially misstated.
If, based on the work we have performed on the other information that we obtained prior to the date of
this auditor’s report, we conclude that there is a material misstatement of this other information, we
are required to report that fact. We have nothing to report in this regard.
When we read the other information not yet received, if we conclude that there is a material
misstatement therein, we are required to communicate the matter to the directors and use our
professional judgement to determine the appropriate action to take.
Responsibilities of the directors for the financial report
The directors of the Company are responsible for the preparation of the financial report that gives a
true and fair view in accordance with Australian Accounting Standards and the Corporations Act 2001
and for such internal control as the directors determine is necessary to enable the preparation of the
financial report that gives a true and fair view and is free from material misstatement, whether due to
fraud or error.
In preparing the financial report, the directors are responsible for assessing the ability of the Group to
continue as a going concern, disclosing, as applicable, matters related to going concern and using the
going concern basis of accounting unless the directors either intend to liquidate the Group or to cease
operations, or have no realistic alternative but to do so.
212
Auditor’s responsibilities for the audit of the financial report
Our objectives are to obtain reasonable assurance about whether the financial report as a whole is free
from material misstatement, whether due to fraud or error, and to issue an auditor’s report that
includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an
audit conducted in accordance with the Australian Auditing Standards will always detect a material
misstatement when it exists. Misstatements can arise from fraud or error and are considered material
if, individually or in the aggregate, they could reasonably be expected to influence the economic
decisions of users taken on the basis of the financial report.
A further description of our responsibilities for the audit of the financial report is located at the
Auditing and Assurance Standards Board website at:
https://www.auasb.gov.au/admin/file/content102/c3/ar1_2020.pdf. This description forms part of
our auditor's report.
Report on the remuneration report
Our opinion on the remuneration report
We have audited the remuneration report included in Item 6 (Directors, Senior Management and
Employees) identified by the title ‘Start of the Remuneration Report for Australian Disclosure
Requirements’ to ‘End of Remuneration Report’ of the directors’ report for the year ended 30 June
2021.
In our opinion, the remuneration report of Mesoblast Limited for the year ended 30 June 2021
complies with section 300A of the Corporations Act 2001.
Responsibilities
The directors of the Company are responsible for the preparation and presentation of the
remuneration report in accordance with section 300A of the Corporations Act 2001. Our responsibility
is to express an opinion on the remuneration report, based on our audit conducted in accordance with
Australian Auditing Standards.
PricewaterhouseCoopers
Sam Lobley
Partner
Melbourne
31 August 2021
213
Item 19.
Exhibits
Item
1.1
1.2
4.1
4.2
4.3†
4.4
4.5
4.6†
4.7†
4.8
4.9#
4.10
4.11
4.12
4.13
4.14†
4.15†
4.16†
4.17†
Constitution of Mesoblast Limited adopted on November 22, 2018 (incorporated by reference to Exhibit 1.1 to the
Company’s Annual Report on Form 20-F filed with the SEC on September 9, 2019).
Certificate of Registration of Mesoblast Limited (incorporated by reference to Exhibit 3.1 to the Company’s Registration
Statement on Form F-1 filed with the SEC on November 2, 2015).
Form of Deposit Agreement between Mesoblast Limited and JPMorgan Chase Bank, N.A., as depositary, and Holders of
the American Depositary Receipts (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on
Form F-1 filed with the SEC on November 2, 2015).
Form of American Depositary Receipt evidencing American Depositary Shares (included in Exhibit 4.1).
Manufacturing Services Agreement by and between Mesoblast Limited and Lonza Walkersville, Inc. and Lonza
Bioscience Singapore Pte. Ltd., dated September 20, 2011 (incorporated by reference to Exhibit 10.6 to the Company’s
Registration Statement on Form F-1 filed with the SEC on November 2, 2015).
Purchase Agreement by and between Mesoblast International Sàrl and Osiris Therapeutics, Inc., dated October 10, 2013
(incorporated by reference to Exhibit 10.7 to the Company’s Registration Statement on Form F-1 filed with the SEC on
November 2, 2015).
Amendment #1 to Purchase Agreement by and between Mesoblast International Sàrl and Osiris Therapeutics, Inc., dated
December 17, 2014 (incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form F-1
filed with the SEC on November 2, 2015).
License Agreement by and between Osiris Acquisition II, Inc. and JCR Pharmaceuticals Co., Ltd., dated August 26,
2003 (incorporated by reference to Exhibit 10.9 to the Company’s Registration Statement on Form F-1 filed with the
SEC on November 2, 2015).
Amendment 1 to License Agreement by and between Osiris Acquisition II, Inc. and JCR Pharmaceuticals Co., Ltd.,
dated June 27, 2005 (incorporated by reference to Exhibit 10.10 to the Company’s Registration Statement on Form F-1
filed with the SEC on November 2, 2015).
Intellectual Property Assignment Deed by and between Mesoblast Limited and Medvet Science Pty Ltd, dated October 4,
2004 (incorporated by reference to Exhibit 10.15 to the Company’s Registration Statement on Form F-1 filed with the
SEC on November 2, 2015).
Employment Agreement, dated August 8, 2014, by and between Mesoblast Limited and Silviu Itescu (incorporated by
reference to Exhibit 10.19 to the Company’s Registration Statement on Form F-1 filed with the SEC on November 2,
2015).
Sublease, by and between Mesoblast Limited and CIT Group Inc., dated September 27, 2011 (incorporated by reference
to Exhibit 10.21 to the Company’s Registration Statement on Form F-1 filed with the SEC on November 2, 2015).
Sublease, by and between Mesoblast Limited and Collins Place Pty Ltd, AMP Capital Investors Limited, and Australia
and New Zealand Banking Group Limited, dated April 21, 2014 (incorporated by reference to Exhibit 10.22 to the
Company’s Registration Statement on Form F-1 filed with the SEC on November 2, 2015).
Form of 2012 Deed of Indemnity, Insurance and Access (incorporated by reference to Exhibit 10.23 to the Company’s
Registration Statement on Form F-1 filed with the SEC on November 2, 2015).
Form of 2014 Deed of Indemnity, Insurance and Access (incorporated by reference to Exhibit 10.24 to the Company’s
Registration Statement on Form F-1 filed with the SEC on November 2, 2015).
Patent License and Settlement Agreement with TiGenix S.A.U., dated December 14, 2017 (incorporated by reference to
Exhibit 4.21 to the Company's Annual Report on Form 20-F filed with the SEC on August 31, 2018).
Loan and Security Agreement by and among Mesoblast Limited, Mesoblast UK Limited, Mesoblast International (UK)
Limited, Mesoblast, Inc., Mesoblast International Sarl and Hercules Capital, Inc., dated March 6, 2018 (incorporated by
reference to Exhibit 4.22 to the Company's Annual Report on Form 20-F filed with the SEC on August 31, 2018).
Loan and Security Agreement by and between Mesoblast Limited, Mesoblast UK Limited, Mesoblast, Inc., Mesoblast
International (UK) Limited, Mesoblast International Sàrl and NQP SPV II, L.P., dated June 29, 2018 (incorporated by
reference to Exhibit 4.23 to the Company's Annual Report on Form 20-F filed with the SEC on August 31, 2018).
Development and Commercialization Agreement by and between Mesoblast Inc., Mesoblast International Sàrl and Tasly
Pharmaceutical Group Co., Ltd. dated July 17, 2018 (incorporated by reference to Exhibit 4.24 to the Company's Annual
Report on Form 20-F filed with the SEC on August 31, 2018).
4.18 Supplementary Agreement for Additional License by and between Mesoblast International Sarl and JCR
4.19
Pharmaceuticals Co., Ltd., dated October 12, 2018 (incorporated by reference to Exhibit 4.25 to the Company’s Annual
Report on Form 20-F filed with the SEC on September 9, 2019).
First Amendment to Loan and Security Agreement by and among Mesoblast Limited, Mesoblast UK Limited, Mesoblast
International (UK) Limited, Mesoblast, Inc., Mesoblast International Sarl and Hercules Capital, Inc., dated January 11,
2019 (incorporated by reference to Exhibit 4.26 to the Company’s Annual Report on Form 20-F filed with the SEC on
September 9, 2019).
214
4.20 Second Supplementary Agreement for Additional License by and between Mesoblast International Sarl and JCR
Pharmaceuticals Co., Ltd., dated June 5, 2019 (incorporated by reference to Exhibit 4.27 to the Company’s Annual
Report on Form 20-F filed with the SEC on September 9, 2019).
Employee Share Option Plan (incorporated by reference to Exhibit 99.1 to the Company’s Registration Statement on
Form S-8 filed with the SEC on July 27, 2020).
4.21
4.22 Development and Commercialization Agreement by and between Mesoblast Limited and Mesoblast International Sàrl
and Grünenthal GmbH, dated September 9, 2019 (incorporated by reference to Exhibit 4.22 to the Company’s Annual
Report on Form 20-F filed with the SEC on September 3, 2020).
4.23 Manufacturing Services Agreement by and between Lonza Biosciences Singapore Pte. Ltd. and Mesoblast International
Sàrl, dated October 9, 2019 (incorporated by reference to Exhibit 4.23 to the Company’s Annual Report on Form 20-F
filed with the SEC on September 3, 2020).
4.24 Second Amendment to Loan and Security Agreement by and among Mesoblast Limited, Mesoblast UK Limited,
Mesoblast International (UK) Limited, Mesoblast, Inc., Mesoblast International Sarl and Hercules Capital, Inc., dated
December 17, 2019 (incorporated by reference to Exhibit 4.24 to the Company’s Annual Report on Form 20-F filed with
the SEC on September 3, 2020).
4.25 Third Amendment to Loan and Security Agreement by and among Mesoblast Limited, Mesoblast UK Limited,
Mesoblast International (UK) Limited, Mesoblast, Inc., Mesoblast International Sarl and Hercules Capital, Inc., dated
February 25, 2020 (incorporated by reference to Exhibit 4.25 to the Company’s Annual Report on Form 20-F filed with
the SEC on September 3, 2020).
4.26 Fourth Amendment to Loan and Security Agreement by and among Mesoblast Limited, Mesoblast UK Limited,
Mesoblast International (UK) Limited, Mesoblast, Inc., Mesoblast International Sarl and Hercules Capital, Inc., dated
August 15, 2020 (incorporated by reference to Exhibit 4.26 to the Company’s Annual Report on Form 20-F filed with
the SEC on September 3, 2020).
4.27 Amendment to Development and Commercialization Agreement by and between Mesoblast Limited and Mesoblast
International Sàrl and Grünenthal GmbH dated June 30, 2021.
4.28 Fifth Amendment to Loan and Security Agreement by and among Mesoblast Limited, Mesoblast UK Limited, Mesoblast
4.29
4.30
4.31
8.1*
10
12.1*
12.2*
13.1*
13.2*
99.1*
99.2*
101.INS
101.SCH
101.CAL
101.DEF
101.LAB
101.PRE
#
*
†
International (UK) Limited, Mesoblast, Inc., Mesoblast International Sarl and Hercules Capital, Inc., dated January 28,
2021.
Sixth Amendment to Loan and Security Agreement by and among Mesoblast Limited, Mesoblast UK Limited,
Mesoblast International (UK) Limited, Mesoblast, Inc., Mesoblast International Sarl and Hercules Capital, Inc., dated
May 26, 2021.
Seventh Amendment to Loan and Security Agreement by and among Mesoblast Limited, Mesoblast UK Limited,
Mesoblast International (UK) Limited, Mesoblast, Inc., Mesoblast International Sarl and Hercules Capital, Inc., dated
August 19, 2021.
Form of Warrant to purchase Ordinary Shares.
List of Significant Subsidiaries of Mesoblast Limited.
Consent of independent registered public accounting firm.
Certification of the Chief Executive Officer pursuant to rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act
of 1934, as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002.
Certification of the Chief Financial Officer pursuant to rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act
of 1934, as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002.
Certification of the Chief Executive Officer pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the
Sarbanes-Oxley Act of 2002
Certification of the Chief Financial Officer pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the
Sarbanes-Oxley Act of 2002
Appendix 4E preliminary final report for the twelve months to June 30, 2021.
Auditor’s independence declaration, dated August 31, 2021.
XBRL Instance Document
XBRL Taxonomy Extension Schema Document
XBRL Taxonomy Extension Calculation Linkbase Document
XBRL Taxonomy Extension Definition Linkbase Document
XBRL Taxonomy Extension Label Linkbase Document
XBRL Taxonomy Extension Presentation Linkbase Document
Indicates management contract or compensatory plan.
Filed herewith.
Confidential treatment has been requested for portions of this exhibit. These portions have been omitted and have been
filed separately with the Securities and Exchange Commission.
Certain confidential portions of this exhibit were omitted by means of marking such portions with brackets (“[***]”)
because the identified confidential portions are not material and would be competitively harmful if publicly disclosed.
215
SIGNATURES
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and
authorized the undersigned to sign this annual report on its behalf.
Mesoblast Limited
By:
Name:
Title:
By:
Name:
Title:
/s/ Joseph R Swedish
Joseph R Swedish
Chairman
/s/ Silviu Itescu
Silviu Itescu
Chief Executive Officer
Dated: August 31, 2021
216
SHAREHOLDER INFORMATION
A. Substantial Shareholders
Holders of substantial holdings of ordinary shares in the Company and the numbers of shares in which they and their associates have a relevant
interest as of 30 September 2021 (as disclosed in substantial holding notices given to the Company under the Corporations Act 2001 (Cth)):
Shareholder
Professor Silviu Itescu
M&G Investment Group
Thorney Holdings
Number of ordinary shares held
68,958,928
51,752,865
24,696,000
B. Distribution of Equity Securities and Voting Rights
Distribution of holders of equity securities as of 30 September 2021:
Range
1 – 1,000
1,001 – 5,000
5,001 – 10,000
10,001 – 100,000
100,001 and over
Total number of holders of equity securities
Number of holders of less than a marketable
parcel of 298 shares ($1.68 per share)
Ordinary shares (i)
Options (ii)(1)
Incentive rights (iii)(2)
Warrants (iv)(3)
0
1
0
41
53
95
17,593
14,407
3,905
3,895
284
40,084
5,854
0
0
3
10
16
29
1
1
(1) There are 42,644,134 options on issue as of 30 September 2021.
(2) 1,500,000 incentive rights are on issue, issued to Kentgrove Capital Pty Ltd.
(3) 15,027,327 warrants are on issue, issued as part of the March 2021 capital raise.
The voting rights attaching to each class of equity securities are:
i. Ordinary shares
On a show of hands, every member present at a meeting, in person or by proxy, shall have one vote and upon a poll each share shall have
one vote.
ii. Options
No voting rights.
iii. Incentive rights
No voting rights.
iv. Warrants
No voting rights.
MESOBLAST LIMITED 2021 ANNUAL REPORT 217
C. Twenty Largest Holders of Quoted Securities
The names of the 20 largest shareholders of each class of quoted equity security as of 30 September 2021 are listed below.
Rank Name
No. of shares held
% of total shares
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
JP Morgan Nominees Australia Pty Limited
HSBC Custody Nominees (Australia) Limited
Professor Silviu Itescu
Citicorp Nominees Pty Limited
UBS Nominees Pty Ltd
Thorney Holdings Pty Ltd
TIGA Trading Pty Ltd
BNP Paribas Nominees Pty Ltd Six Sis Ltd
Independent Asset Management Pty Limited
Merrill Lynch (Australia) Nominees Pty Limited
National Nominees Limited
BNP Paribas Noms Pty Ltd
Mr Gregory John Matthews & Mrs Janine Marie Matthews
CS Third Nominees Pty Limited
BNP Paribas Nominees Pty Ltd
HSBC Custody Nominees (Australia) Limited
Kentgrove Capital Pty Ltd
Tigcorp Nominees Pty Ltd
National Nominees Limited
Lalp Pty Ltd
D. Securities under escrow
There are no securities currently under escrow.
E. On-Market Buy-Back
There is no current on-market buy-back of the Company’s ordinary shares.
F. Stock Exchanges
121,770,725
98,085,940
67,751,838
33,879,000
11,867,428
10,000,000
10,000,000
9,345,724
7,870,558
5,796,431
4,383,937
4,018,197
3,918,942
3,700,135
2,977,948
2,402,815
2,000,100
1,995,000
1,888,878
1,647,144
18.77
15.12
10.44
5.22
1.83
1.54
1.54
1.44
1.21
0.89
0.68
0.62
0.60
0.57
0.46
0.37
0.31
0.31
0.29
0.25
405,300,740
62.48
The Company’s ordinary shares are listed on the Australian Securities Exchange and are traded under the symbol ‘MSB’. The Company’s
American Depositary Shares, each representing five ordinary shares, are listed on the NASDAQ Global Select Market and are traded under
the symbol ‘MESO’.
218 MESOBLAST LIMITED 2021 ANNUAL REPORT
Share Registry
Link Market Services Limited
Level 13, Tower 4
727 Collins Street
Melbourne
Victoria 3000
Australia
Telephone +61 1300 554 474
Facsimile +61 2 9287 0303
www.linkmarketservices.com.au
Auditors
PricewaterhouseCoopers
Level 19
2 Riverside Quay
Southbank
Victoria 3006
Australia
Telephone +61 3 8603 1000
Facsimile +61 3 8603 1999
CORPORATE DIRECTORY
Directors
Joseph Swedish (Chairman)
Silviu Itescu
William Burns
Philip Facchina
Donal O’Dwyer
Eric Rose
Michael Spooner
Shawn Cline Tomasello
Company Secretary
Niva Sivakumar
Registered Office
Level 38
55 Collins Street
Melbourne VIC 3000
Australia
Telephone +61 3 9639 6036
Facsimile +61 3 9639 6030
Country of Incorporation
Australia
Listing
Australian Securities Exchange
(ASX Code: MSB)
NASDAQ Global Select Market
(NASDAQ Code: MESO)
Website
www.mesoblast.com
MESOBLAST LIMITED 2021 ANNUAL REPORT 219
www.mesoblast.com